US20120071870A1 - Low Profile Electrode Assembly - Google Patents

Abstract

A tissue electrode assembly includes a membrane configured to form an expandable, conformable body that is deployable in a patient. The assembly further includes a flexible circuit positioned on a surface of the membrane and comprising at least one base substrate layer, at least one insulating layer and at least one planar conducting layer. An electrically-conductive electrode covers at least a portion of the flexible circuit and a portion of the surface of the membrane not covered by the flexible circuit, wherein the electrically-conductive electrode is foldable upon itself with the membrane to a delivery conformation having a diameter suitable for minimally-invasive delivery of the assembly to the patient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation-in-part of U.S. application Ser. No. 12/616,758, filed Nov. 11, 2009; which application claims priority to U.S. Provisional Application No. 61/113,228, filed Nov. 11, 2008, and U.S. Provisional Application No. 61/160,204, filed Mar. 13, 2009, and U.S. Provisional Application No. 61/179,654, filed May 19, 2009; and U.S. Provisional Application No. 61/232,756, filed Aug. 10, 2009; and U.S. Provisional Application No. 61/253,683, filed Oct. 21, 2009; all of which are incorporated herein by reference.
• This application claims the benefit of U.S. Provisional Application No. 61/334,154, filed May 12, 2010, the entire content of which is incorporated by reference as if fully set forth herein.
INCORPORATION BY REFERENCE
• All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
BACKGROUND
• Energy transmission to tissues can be used to treat a variety of medical conditions. Electrodes can be used to deliver energy to tissues and cells for the purpose of sensing, mapping, ablating, and/or stimulate muscles and/or nerves. Stimulation of muscles and/or nerves can be used to trigger signals to the brain or directly to a specified muscle cell/group. When the treatment requires removing or destroying a target tissue, thermal ablation therapy can be used to heat a target tissue with a surgical instrument such as a needle or probe electrode coupled to an energy source that heats the probe tip, the target tissue, or both. In such cases the thermal energy may be delivered directly by heating or cooling the probe or indirectly by generating energy fields within the tissue which in turn generate heat, or both. Energy fields commonly used to create heat indirectly are RF and acoustic energy fields. The goal for most ablation procedures is to achieve cell death quickly, precisely and with minimal to no collateral damage.
• In the case of thermal ablation therapy for terminating destructive cardiac conductive pathways, energy can be delivered to the aberrant cells using minimally-invasive techniques such as an electrode-tip catheter. Pulmonary vein isolation via radio frequency catheter ablation has been demonstrated to be an effective treatment for some patients experiencing atrial fibrillation (AF). The cornerstone of the AF ablation procedures is electrical isolation of relatively large pulmonary vein antra. Ablation of large confluent areas or lines of ablation with older generation AF ablation devices is accomplished by point to point manipulation and RF application with the single electrode tip. The single electrode catheter technique is extremely time-consuming, complex and fraught by subjectivity. Furthermore, efficient and complete mapping of the electrical activity in target tissues often requires the placement of multiple catheters in the left atrium, the use of a 3D-mapping, and/or steering system. It is often desirable to create relatively large surface area lesions with relatively shallow depths of ablation.
• Newer larger electrode arrays for “one shot” ablation have been used to improve catheter ablation treatments. These ablation systems have been adopted as a way to provide full contact to tissues having a complex 3-D anatomy and an overall larger lesion area. But known devices incorporate electrodes that are bulky, stiff and limited in their ability to be packed efficiently and effectively into the small space of the treatment catheter. The stiffness of these devices limits conformability against the tissue resulting in the need for additional repositioning and overlapping patterns to ensure uninterrupted lines of ablation.
SUMMARY
• One aspect of the disclosure is a catheter and electrode assembly comprising: an elongate catheter body comprising a distal portion; an expandable electrode structure coupled to the distal portion, wherein the expandable electrode structure comprises an expandable membrane with an expanded configuration, and a branched flexible circuit having a substrate layer and planar conducting layer electrically coupled to a plurality of radio frequency ablation electrodes and at least one sensing electrode, wherein in the expanded configuration at least four of the electrodes are disposed in an array on a distal surface of the membrane.
• In some embodiments the at least four electrodes are adapted to be substantially coplanar with a distal tip of the catheter body when the membrane is in the expanded configuration.
• In some embodiments the at least four electrodes are distal to the distal tip of the catheter when the membrane is in the expanded configuration.
• The assembly can additional comprise a first membrane portion comprising at least 15% of the surface area of the membrane that is distal to a distal tip of the catheter body, and wherein the at least four electrodes are disposed on the first membrane portion. In some embodiments at least 10% of the volume of the membrane is distal to a distal tip of the catheter when the membrane is in the expanded configuration.
• In some embodiments first and second opposite sides of a surface of the membrane are coupled to the catheter body.
• In some embodiments a plurality of perforation holes traverse the membrane.
• In some embodiments the assembly further comprises an annular introducer wherein the introducer surrounds the expandable membrane and confines the diameter thereof to less than about 0.2 inches. The introducer can be adapted to engage a collapsed exterior of the expandable membrane and confine a portion of the membrane substantially distal to the distal end of the catheter body.
• In some embodiments the expanded configuration is an inflated configuration.
• One aspect of the disclosure is a unitary flexible circuit comprising: a proximal end, a distal end, and an intermediate portion, wherein the proximal end is coupled to an electrical source, the intermediate portion is comprised of a plurality of flexible branches separated from one another along their lengths, wherein at least one branch has an insulating layer along a portion thereof and at least one branch is electrically connected to an electrode adapted to deliver radio frequency energy, wherein the flexible branches conform to a portion of a medical device adapted to be minimally-invasively delivered to a location within a subject, and wherein the plurality of branches are coupled to one another distal to the intermediate portion.
• In some embodiments the length of at least one branch in the intermediate portion is between about 1 cm and about 5 cm.
• In some embodiments the flexible branches conform to a radially outer surface of the portion of the medical device.
• In some embodiments the branches of the intermediate portion conform to the portion of the medical device such that they are oriented in a configuration surrounding a longitudinal axis of the medical device. The branches can extend substantially 360 degrees around the longitudinal axis and at least two of the plurality of branches are separated by more than 30 degrees from an adjacent branch. In some embodiments any two branches are separated by more than 10 degrees. In some embodiments any two branches are separated by more than 90 degrees.
• In some embodiments the plurality of branches of the intermediate portion are fixed on the medical device such that the medical device maintains the separation between the branches. The portion of the medical device can be an expandable membrane. The orientation of the branches of the intermediate portion can depend on the inflation of the expandable membrane. A portion of the expandable membrane and a portion of a plurality of the branches can be located distally to the distal end when the expandable membrane is in an expanded configuration.
• In some embodiments at least two of the branches are comprised of a plurality of electrodes adapted to deliver radio frequency (RF) energy. The distal end can be comprised of a sensing electrode spaced apart from the plurality of electrodes.
• In some embodiments the proximal end is coupled to a catheter. The catheter can be sealed along a length thereof extending from the proximal end to the intermediate portion.
• In some embodiments at least three branches terminate in a connector at the proximal end. In some embodiment portions of the medical device are adapted to be folded by selective orientation of the plurality of branches.
BRIEF DESCRIPTION OF THE DRAWINGS
• These and other aspects will now be described in detail with reference to the following drawings. Generally speaking the figures are not to scale in absolute terms or comparatively but are intended to be illustrative of claimed features. Also, relative placement of features and elements may be modified for the purpose of illustrative clarity.
• FIGS. 1A-1B show enlarged, cross-sectional schematic views of an embodiment of an electrode assembly.
• FIG. 1C illustrates an embodiment of a flex circuit for an electrode device.
• FIG. 1D illustrates an embodiment of an electrode assembly including a membrane, flex circuit and electrodes.
• FIGS. 2A-2E illustrate cross-sectional views of various embodiments of an electrode assembly.
• FIG. 2F illustrates a cross-sectional view of an existing flex circuit.
• FIGS. 3A-3E illustrate top views of various embodiments of a flex circuit.
• FIGS. 4A-4C illustrate cross-sectional views of an embodiment of an electrode assembly in different folding configurations.
• FIGS. 5A-5I illustrate various exemplary electrode patterns and electrode shapes.
• FIGS. 6A-6B illustrate groupings of multiple smaller electrodes creating a larger electrode.
• FIG. 6C illustrates an embodiment of an electrode that includes a small mapping electrode.
• FIG. 6D illustrates an embodiment of an electrode configured as a dual spiral with the inner ends merged.
• FIGS. 7A-7E illustrate various embodiments of electrodes and a flex circuit having mapping electrodes and temperature sensors.
• FIG. 8 illustrates an embodiment of the flex circuitry wiring.
• FIGS. 9A-9B illustrate various electrode configurations and activation mechanisms.
• FIG. 10 illustrates an embodiment of electrode activation using an electrode sleeve.
• FIG. 11 illustrates another embodiment of electrode activation using an electrode sleeve.
• FIG. 12 shows an embodiment of an electrode pattern that can be used for ablation.
• FIGS. 13A-13B illustrate embodiments of a flex circuit at the electrodes.
• FIGS. 14A-14B illustrate embodiments of an electrode assembly having a cylindrical electrode element and an electrode sheath.
• FIGS. 15A-15B illustrate embodiments of an electrode assembly having a cylindrical electrode element within a sheath.
• FIGS. 16A-16B illustrate embodiments of an electrode assembly having a cylindrical electrode element.
• FIGS. 17A-17G illustrate embodiments of an electrode assembly having an expandable electrode structure.
• FIGS. 18A-18S illustrate embodiments of an electrode assembly having an expandable electrode structure.
• FIGS. 19A-19F illustrate embodiments of an electrode assembly having an expandable electrode structure that can be deployed asymmetrically and/or can be of various shapes.
• FIGS. 20A-20C illustrate embodiments of an electrode assembly having an expandable electrode structure that can be deployed into various shapes.
• FIGS. 21A-21E illustrate the tissue conformability of embodiments of the expandable electrode structure.
• FIGS. 22A-22C illustrate embodiments of electrode deposition onto a deployable membrane.
• FIGS. 23A-23H illustrate embodiments of flex circuit routing through an electrode device and electrode deposition onto a deployable membrane.
• FIGS. 24A-24B illustrate folding of an embodiment of a deployable membrane having flex circuits attached thereto.
• FIGS. 25A-25C illustrate embodiments of a catheter having features to improve flexibility and torque control.
• FIGS. 26A-26C illustrate embodiments of a steerable catheter having a membrane mounted thereto.
• FIGS. 27A-27C illustrate embodiments of a steerable catheter having a membrane mounted thereto and steerable elements mounted to the membrane.
• FIGS. 28A-28F illustrate an embodiment of an expandable electrode structure having mapping and ablation electrodes deposited thereon.
• FIGS. 29A-29C illustrate embodiments of an electrode assembly integrated with additional expandable structures that can be used for mapping and/or anchoring.
• FIG. 30 illustrates an embodiment of an electrode assembly integrated with a mapping catheter.
• FIGS. 31A-31B illustrate an embodiment of a linear mapping electrode catheter.
• FIGS. 32A-32B illustrate an embodiment of a self-expanding mapping electrode structure.
• FIGS. 33A-33D illustrate embodiments of a mapping electrode structure.
• FIGS. 34A-34F illustrate embodiments of a flex circuit that can be used for a mapping electrode structure.
• FIG. 35 illustrates an embodiment of an electrode support structure.
• FIGS. 36A-36B illustrate an embodiment of an electrode system for use near a heat sink.
• FIGS. 37A-37F illustrate embodiments of irrigation holes positioned near one or more electrodes.
• FIGS. 38A-38I illustrate embodiments of a visualization system for use with an electrode assembly.
• FIGS. 38J-R illustrate exemplary optic structures and exemplary expandable membranes.
• FIGS. 39A-39E illustrate various embodiments of radiopaque marker systems.
• FIGS. 40A-40E illustrate various embodiments of radiopaque marker systems.
• FIGS. 41A-41B illustrates embodiments for sensing tissue contact via impedance measurements.
• FIGS. 41C-41D illustrate various embodiments of micro-switches that can be used to activate electrodes.
• FIG. 42 illustrates an embodiment of a tissue contact assessment mechanism that can be incorporated into the electrode assembly.
• FIG. 43 illustrates another embodiment of a tissue contact assessment mechanism that can be incorporated into the electrode assembly.
• FIGS. 44A-44F illustrate various embodiments of an anchoring system to create ablation lines.
• FIGS. 45A-45B illustrate embodiments of an anchoring system for use with an electrode assembly.
• FIGS. 46A-46B illustrate embodiments of a suction tip anchoring and electrode assembly.
• FIG. 47 illustrates an embodiment of a suction tip anchoring and electrode assembly.
• FIGS. 48A-48B illustrate an embodiment of a two arm suction tip anchoring and electrode assembly.
• FIGS. 49A-49D illustrate an embodiment of a suction tip anchoring and electrode assembly for creating continuous energy transmission lines.
• FIG. 50 illustrates an embodiment of a suction anchoring and electrode assembly.
• FIGS. 51A-51C illustrate an embodiment of a suction anchoring and electrode assembly for creating continuous energy transmission lines.
• FIGS. 52A-52D illustrate an embodiment of an electrode system including an inner suction catheter and an outer electrode catheter.
• FIGS. 53A-53E illustrate an embodiment of a suction electrode catheter having an expandable region.
• FIGS. 54A-54D illustrate an embodiment of a suction electrode catheter having more than one expandable region.
• FIGS. 55A-55C illustrate an embodiment of a suction electrode catheter having more than one expandable region.
• FIGS. 56A-56E illustrate various embodiments of a rapid exchange electrode sheath and anchoring catheter.
• FIGS. 57A-57C illustrate a sheathing device that can be used to sheath an electrode assembly for minimally-invasive delivery.
• FIGS. 58A-58K illustrate a method of sheathing the electrode assembly for minimally-invasive delivery.
• FIG. 59 illustrates a device that can be used to assemble the electrode assembly.
• FIG. 60A-60D illustrate a flexible membrane incorporating electrodes disposed around an expandable structure.
• FIG. 61A-61C illustrates two embodiments of an electrode supporting membrane and shaft interface.
• FIG. 62A-62B illustrates an alternate embodiment of an electrode supporting membrane and shaft interface.
• FIG. 63A-63C illustrates an alternate embodiment of an electrode supporting membrane and shaft interface.
• FIG. 64 illustrates a system for using an electrode assembly.
• FIG. 65 illustrates a sheathing device.
• FIG. 66 illustrates a means of fabricating an electrode.
• FIGS. 67A-67B illustrate arrangements of RFG electrode interfacing.
DETAILED DESCRIPTION
• The use of minimally-invasive electrode devices, especially those for use in regions of the body having somewhat complicated 3-D anatomy, has been hindered by the conformability, flexibility and overall profile of the device as well as the electrode stimulation, ablation, mapping effectiveness. Disclosed herein are devices having electrode assemblies that incorporate one or more flexible electrodes deposited over one or more flex circuits positioned on a deployable, flexible membrane. The flexible electrodes can be used to sense, map, ablate, or stimulate muscles and/or nerves. Energy transmission through the electrodes can be accomplished over large surfaces such as the lining within an organ or selective regions for treatment of tumors, for example. Stimulation of muscles and/or nerves can be used to trigger signals to the brain or directly to a specified muscle cell/group. The electrode assemblies can also be used as temporary implants for the purpose of providing or generating thermal energy for a specified period of time, such as can be needed for stimulation of nerves and/or muscles. It should be appreciated that the electrodes and electrode assemblies described herein can be used for a variety of functions as is known in the art, including but not limited to, ablation, mapping, sensing, and/or stimulating a variety of cells types and tissue types. When an electrode is described herein to perform a particular function, such as ablation, it should not be construed to mean the electrode is incapable of performing another electrode function such as mapping, sensing or stimulating.
• The electrode assemblies described herein are readily conformable, foldable and have a very low profile for minimally-invasive procedures as well as a large overall surface area. The electrode assemblies described herein allow for superior apposition to the target site and limit the number of catheter manipulations required. Further, the electrode assemblies described herein can greatly reduced procedure times and reduce the necessary skill level required to achieve successful results.
• Although the devices, assemblies and methods of the present disclosure are at times described in terms of mapping, ablating or sensing tissue which creates aberrant electrical signals in the heart, it should be appreciated that the devices described herein can be used to treat a variety of conditions through sensing, mapping, ablation and/or stimulation in a variety of anatomical locations and that other indications are considered herein. The devices, assemblies and methods described herein are not limited to treating cardiac conditions or any other particular indication and can be used for any treatment in which an energy delivery system is indicated, and in particular, a minimally-invasive treatment.
• FIGS. 1A-1B show enlarged, cross-sectional schematic views of an embodiment of anelectrode assembly105. Theelectrode assembly105 can include aflexible membrane34, one ormore flex circuits89 and one ormore electrodes6. Theflex circuit89 can include abase substrate52, a conductinglayer96 and adielectric layer100. As shown inFIG. 1C, theflex circuit89 can diverge from one or moremain branches17 into multipledistal branches87, each having one or more conductive traces16 (not shown) which each lead to one or more conductive pads59 (not shown). Theflex circuit89 as shown inFIG. 1C can be wrapped around an expandable membrane, such as a balloon (seeFIG. 23G or23H), so that themain branches17 come together at the shaft. In an embodiment, eachconductive trace16 can include at least twoconductive pads59. Theconductive pad59 can be a region of theconductive trace16 that has an exposed, non-insulated portion of the conductinglayer96. Theelectrode6 can be electrically coupled to theflex circuit89 via the conductive pad59 (not shown) of theconductive layer96. Thebase substrate52 can also have a wider surface for better adhesion of theflex circuit89 to themembrane34. With a larger base substrate surface, theconductive pad59 can have a larger surface to electrically connect to theelectrode6. It should be appreciated that the embodiment of the electrode assembly shown inFIGS. 1A-1C is exemplary and that variations in the structure, shape, and relative positions of the components are possible.
• Eachelectrode6 can be a thin, electro-conductive film that covers at least a portion of theflex circuit89 and a portion of the outer surface of themembrane34.FIG. 1D illustrates a portion of amembrane34 supporting a one distal branch of theflex circuit87. The figure shows twoelectrodes6 that overlap separateconductive pads59 of theflex circuit89, the corresponding conductive traces16, and a portion of the flex circuitdistal branch87. Theelectrode6 can have a surface area or diameter that is significantly larger than theconductive pad59. Because theelectrode6 has a larger surface area it also covers a portion of themembrane34 not covered by theconductive pad59 or the flex circuitdistal branch87.
• Theelectrode assembly105 can be deployed to deliver energy to a target tissue. When deployed, eachelectrode6 on themembrane34, both alone and in combination, can cover a relatively large surface area of themembrane34 with which to contact target tissues. Despite the large overall surface area of theelectrodes6 and the components of theflex circuit89 covering theflexible membrane34, theelectrode assembly105 can be compactly folded into a small diameter such that theelectrode assembly105 can be delivered, for example, through small access channels for minimally-invasive delivery.
Flexible Electronics
• The electrode devices described herein incorporate flexible electronics that are foldable to a very low profile for minimally-invasive delivery in contrast to a relatively stiff and bulky electrode assembly. Upon reaching the target tissue, the electrode devices described herein can unfold to reveal a very large surface area electrode assembly that can be readily conformable with the target tissues.
Flex Circuit
• As mentioned above, theelectrode assembly105 of the devices described herein can include one or more branchingflex circuits89. Theflex circuit89 can include abase substrate52, a conductinglayer96 and adielectric layer100 as will be discussed in more detail below. Still with respect to FIG.1D, theflex circuit89 can include one or more main proximal branches17 (not shown) that can divide into multiple conductivedistal branches87. Each distal branch can contain multipleconductive traces16, each having one or moreconductive pads59. Theconductive pad59 has an electrically-conductive region formed by exposure of the conductinglayer96 upon removal of a portion of the overlying insulatingdielectric layer100. The exposed portion ofconductive layer96 can contact theconductive film electrode6. Theconductive pad59 can be a region of theconductive trace16 that has a larger surface area due to a largerbase substrate layer52 and insulating dielectric layer100 (not shown). The method ofconductive trace16 termination is created as known in the art. These regions of wider and larger surface areas can be used for better adherence to the membrane.
• As shown inFIG. 1C, thedistal branches87 of theflex circuit89 can form a pattern ofdistal branches87 that can spread out across themembrane34. The branching pattern can vary and includes a fractal, self-repeating pattern or other symmetrical pattern, as well as an unsymmetrical pattern. Theflex circuit89 can include branches that are sinusoidal in shape so that some elongations between electrodes can be achieved.Multiple flex circuits89 can be used to accommodate for the quantity and location of themultiple electrodes6. Some elements of theflex circuitry89 can havebridging elements88 that facilitate handling during manufacturing (seeFIG. 3C).
• As shown inFIGS. 2A-2E, theflex circuit89 and multipleconductive traces16 can be constructed using laminations of various materials, but generally includes abase substrate52, an electricallyconductive layer96 and an electrically insulatinglayer100. In an embodiment, the multipleconductive traces16 include a bottom insulatingsubstrate layer52, a middleconductive layer96 and a top insulatingdielectric layer100. The dielectric or top insulatinglayer100 can be removed as is known in the art to expose a small region of theconductive layer96. For example, a laser can be used to remove thedielectric layer100 by etching as will be discussed in more detail below. In other embodiments, an adhesive layer can be used between the layers described above. In other embodiments, multiple layers of conductivity and/or dielectric and/or adhesive can be included.
• The materials used in the laminations of theflex circuit89 can vary. Thebase substrate layer52 and the electrically insulatinglayer100 can be a material such as, but not limited to, a thin flexible plastic substrate, polyimide, polyester, PET (polyethylene terephthalate), PEEK (polyaryletheretherketone), PTFE (polytetrafluoroethylene), PEN (polyethylene naphthalate), LCP (liquid crystal polymer), PIC (photoimageable coverlay), thin epoxy glass, polyimide glass, acrylic adhesive or other material. In an embodiment, the substrate or bottom insulatinglayer52 and the dielectric or top insulatinglayer100 can be the same materials. In another embodiment, the substrate and the dielectric layers are different materials. For example, the substrate can be polyimide and the dielectric can be polyimide glass or similar material.
• The conductor orconductive layer96 can be a material such as, but not limited to, a metal or metal foil of copper, gold, silver, tin, nickel, steel, cupronickel (copper-nickel alloy), KOVAR (nickel-cobalt ferrous alloy) or other material. In an embodiment, more than one conductive material can be used in theconductive layer96. In an embodiment, aconductive layer96 of copper can be plated with a thin layer of an additional conductive material at theconductive pad59. In an embodiment, the thin layer of additional conductive material can be gold. The flex circuit and its components can be manufactured using techniques as known in the art.
• Still with respect toFIGS. 2A-2E, theflex circuit89 and associated conductive traces16 andconductive pads59 can be coupled to themembrane34 by a variety of techniques known in the art to affix a metallic or polymer, shaped member onto another surface as are known in the art. For example, anadhesive film95 or other material can be used to adhere the bottom layer of theflex circuit89 to themembrane34 as will be discussed in more detail below. Theadhesive film95 can be conductive or non-conductive. For example, an adhesive95 that is conductive can be laid over portions of the electrodes to adhere to the exposedconductive layer96.Adhesive95 that is not conductive can be used to bond the rest of the components to themembrane34, for example to secure an end region of theflex circuit89 to themembrane34. Theflex circuit89 can be direct formed into themembrane34 as will be discussed in detail below. Alternatively the conductive layer may be plated directly onto the substrate without the use of an intervening layer of adhesive.
• Although theconductive layer96 can be relatively narrow, it can also have a surface that is somewhat planar, as opposed to having a cylindrical geometry. The planar surface of theconductive layer96 can have a width and thickness that is optimized for carrying current to theelectrodes6. Further, the plurality ofconductive traces16 can be grouped to create a planar surface width optimized to bond theflex circuit89 to themembrane34. Theflex circuit89 can also include one ormore holes53 incorporated through thebase substrate52 and the insulatinglayer100 to allow for adhesive to wick through to improve adhesion of theflex circuit89 to the membrane34 (seeFIG. 1D).
• FIGS. 2A-2E illustrate various lamination configurations of the flex circuit andelectrode assembly105. The lamination configurations are exemplary and variations are possible.FIG. 2A shows anadhesive layer95 that is electrically non-conductive adjacent to theelectrode6 and covers a portion of themembrane34 and the flex circuitdistal branch89. The conductive section of theconductive layer96 contacts theelectrode6. Anadhesive layer95 can also be applied over the top of the flex circuitdistal branch87 near an end where it contacts theelectrode6 to secure the end of thedistal branch87 to themembrane34. The adhesive applied over this portion can be conductive to increase the surface area of theelectrode6. In other embodiments, theelectrode6 itself can also serve as an adhesive for portions of theflex circuit89 when conductivity is desired.
• FIG. 2B shows aconductive trace16 bonded to amembrane34 using an adhesive95. An exposed portion of theconductive layer96, such as where the insulatinglayer100 has been removed, can face away from themembrane34 surface such that it does not come in direct contact with themembrane34. Since theconductive layer96 faces away from themembrane34, a non-conductive adhesive can be applied. Theelectrode6 covers the exposed portion of theconductive layer96 as well as a portion of themembrane34 and flex circuitdistal branch87.FIG. 2C shows thedistal branch87 of aflex circuit89 that is adhered to a region of an inner surface of themembrane34 as well as the outer surface of themembrane34. The flex circuitdistal branch87 pierces through the membrane surface. In an embodiment, anadhesive layer95 is not used to fix theflex circuit89 to the inner surface of themembrane34. The adhesive in this case can be non-conductive as theconductive layer96 faces away from themembrane34.FIGS. 2D-2E shows the distal branches offlex circuit89 directly coupled to amembrane structure34.FIG. 2D shows amembrane34 encapsulating of thebase substrate52 of theflex circuit89. The exposedconductive layer96 is covered by theelectrode6 which also covers part of the membrane.FIG. 2E shows anelectrode6 embedded within themembrane34 and theconductive layer96 of theflex circuit89 covering a portion of the electrode such that theelectrode6 and exposedconductive layer96 are in contact.
• The flexible and thin components of theflex circuit89 contribute to the low profile and low bulk of theelectrode assembly105 such that it can fold to a very small profile for minimally-invasive delivery. Theflex circuit89 can be affixed to themembrane34 such that themembrane34 andelectrodes6 undergo preferential folding, for example between or across theflex circuits89. The folding can occur in an organized, controlled and repetitive manner. Theflex circuit89 can aid in better packing as it straightens out during folding and encourages the membrane to do the same.FIG. 2F shows an embodiment of an existing flex circuit with multiple layers of conductive, adhesive and dielectric layers.
• FIGS. 3A-3B show two embodiments of a flex circuit that can be used to power the electrodes described herein. The embodiments of3A and3B are exemplary and are not intended to be limiting.FIG. 3A shows aflex circuit89 that includes an array ofdistal branches87 extending from a proximal mainflex circuit lead17 toward the distal end. Thedistal branches87 can split forming a Y-junction. This allows theflex circuit89 to continue at various angles from the mainflex circuit lead17 and can be used to wrap amembrane34, for example an expandable balloon-shaped membrane, at different latitudes along the surface. Thedistal branch87 which can contain multipleconductive traces16 can be electrically insulated through the length of theflex circuit89 and theconductive layer96 exposed at specific points on theflex circuit89, for example at aconductive pad59 surrounded by an area of enlarged width ordiameter substrate layer52 and dielectric100 (not shown). The substrate layers52 are shown includingholes53 through thesubstrate52 and insulating dielectric layer100 (not shown) to facilitate attachment with, for example an adhesive. The embodiment of theflex circuit89 illustrated inFIG. 3A can power four electrodes (not shown) via the fourconductive pads59. The embodiment is shown as including twotemperature sensors90, but it should be appreciated that fewer or more than twotemperature sensors90 can be included. It should be understood that the temperature sensor also requires aconductive pad59 for power. The conductive traces for thetemperature sensors90 can also be used to simultaneously power a mapping electrode (not shown). In an embodiment fiveflex circuits89 can be used to power twenty ablation electrodes, ten mapping electrodes and tentemperature sensors90.
• FIG. 3B shows a different embodiment of theflex circuit89 in which all the flex circuits are integrated into a single piece that can be split into all thedistal branches87 needed to power theelectrodes6. Theflex circuit89 in this embodiment is a single unit that is split into a number of branches. Thesebranches87 can be connected to one another via asmall bridge88 on the substrate at various points throughout the length of the flex circuit89 (seeFIG. 3C). Theflex circuit89 can be rolled up into a small profile to insert theflex circuit89 into a catheter for assembly. Since theflex circuit89 can be split intobranches87, these cuts help facilitate the flexing and bending necessary for assembly and during use. Theflex circuit89 can be placed inside a catheter and at the distal end; eachbranch87 can peel away at the distal end to form a Y-junction as shown inFIG. 3A. Theflex circuit89 can then be attached to themembrane34 at the various desired positions. Theflex circuit89 can also include staggeredconductive pads59. Staggering the position of theconductive pads59 can aid in providing a low profile to reduce a stack up of the regions of enlarged width ordiameter substrate52. The distal end region of thebranches87 can contain an extra amount of length to be used assacrificial tabs102. Thesesacrificial tabs102 can be used to provide for consistent tensioning of theflex circuit branches87 during assembly. Thetabs102 can be mounted to an assembly fixture (seeFIG. 59) to ensure the locations of eachtab102 and eachbranch87 of theflex circuit89 is properly positioned relative to themembrane34 and/orshaft57.
• FIG. 3D shows an alternate embodiment of the distal end of the flex circuit shown inFIG. 3B. In this embodiment thebranches87 are separated as in the flex circuit ofFIG. 3B but, in contrast to the embodiment ofFIG. 3B, are again remerged into a single length of substrate, tab116 (at the top in the figure), at the very distal end of the flex circuit. Thistab116 wraps the distal end around a shaft, thereby forming a ring structure at the distal end of the flex circuit that may be locked in place. Incorporated intab116 isslot117 into which the free section oftab116 can be slipped and affixed, thereby forming a ring of substrate material. Also incorporated in the flex circuit ofFIG. 3D is anadditional tab116 and slot117 at the proximal end of the branches (shown at the bottom of the figure). The section between the twoattachment tabs116 is the intermediate portion. In such an embodiment the flex circuit may be affixed to themembrane34 of an expandable element continuously on the surface ofmembrane34 or at multiple points onmembrane34, or may be affixed only at the proximal and distal edges of themembrane34. Such an embodiment can have advantages both in manufacturing and packing relative to delivery. Also shown inFIG. 3D are staggeredconductive pads59a,59b, and59c.
• The intermediate portion is comprised of a plurality of individual branches separated from one another along their lengths, wherein at least one branch has an insulating layer along a portion thereof and at least one branch is electrically connected to an electrode adapted to deliver radio frequency energy. The plurality of branches, as shown, are coupled to one another distal to the intermediate portion where they are separated along their lengths.
• FIG. 3E is an exemplary completeflex circuit element89 viewed from the substrate side which incorporates the distal end of theflex circuit89 illustrated inFIG. 3D.Flex circuit89 incorporatesbends118 which facilitate the manufacture offlex circuit89. During assembly of the electrode assembly, bends118 are folded such thatflex circuit89 may be wrapped around or within a shaft of the delivery system. In such a fashion the flex circuit can span from the electrodes of the electrode assembly to a connector at a handle (not shown) into whichflex circuit interface119 is connected. A flex circuit of a length greater than about 12 inches can therefore be manufactured on a surface which is no greater than about 12 inches in any dimension. In some instances it may be desirable to create multiple segments offlex circuit89 and connect them as part of the catheter fabrication process. In such cases the flex circuit may be segmented normal to primary direction of the conductors. Convenient locations for such segments to start and end are at thefolds108, in which case the number of connections could replace a same number of folds. The connections thus knit the segments into a unitary structure. Alternatively the direction of segmentation can be parallel to the primary direction of the conductors, in which case the segments would travel the same length as the single structures previously described.Tabs116 can be modified to interface between segments thus allowing the segments to be knit into a unitary structure.
• In some embodiments the length of at least one branch in the intermediate portion is between about 1 cm and about 5 cm.
• The circuit shown inFIG. 3E may alternatively be printed on a tubular substrate which is the full unfolded length of the circuit. In such an embodiment the tubing base substrate may be slotted in areas requiring expansion or additional flexibility. Circuit printing techniques such as those used in InkJet Flex circuits can be used in these embodiments. Alternatively, the circuit can be printed on one full length of the circuit, eliminating the need for bends. If incorporated, the folds allow for printing on more readily available fabrication equipment.
• In some situations where the number of electrodes and ancillary sensors is minimal the flex circuit may be replaced by wires affixed to theflexible membrane34.FIG. 66 illustrates such an arrangement. In such cases a wire lead which has been coined at its distal end to create a thin section of sufficient flexibility and surface are to act as the electrode of the flex circuit. Coinedwire145 can replace aflex circuit branch87. The coinedwire145 may be affixed toflexible membrane34 using anadhesive film95. The coinedwire145 may be affixed over an electrode with a conductive adhesive as shown or may be affixed with a non-conductive adhesive and the electrode fabricated over the adhered coined wire145 (not shown). The sensor leads can be treated in the same fashion if required.
Electrodes
• One ormore electrodes6 can contact specified non-insulated sections of aconductive trace16 of theflex circuit89, theconductive pad59, as well as a portion of thedeployable membrane34 and insulated portion of theflex circuit89. Theelectrodes6 can be a thin film material that can be repeatedly folded such that theelectrode6 andmembrane34 can be compacted into a small diameter for minimally-invasive delivery. The conductive material of theelectrode6 has a relatively large surface area compared to theconductive pad59 it contacts, which provides for a large overall electrode area.
• Despite this large surface area, theelectrodes6 do not significantly increase the stiffness of themembrane34 and can fold with themembrane34.FIGS. 4A-4C show an embodiment of the interface bond where themembrane34 is manufactured separately from theflex circuit89 and theelectrode6. Theelectrode6 can be deposited such that it contacts specified non-insulated section of theconductive layer96 and a portion of themembrane34.FIG. 4A shows a slight curvature in themembrane34 and how theelectrode6 can follow this curvature.FIG. 4B shows theelectrode6 folded away from themembrane34 whereasFIG. 4C shows theelectrode6 folded inwards and possibly contacting itself. Despite the large surface area covered, thethin electrode6 and themembrane34 can still be folded (seeFIGS. 4B and 4C). Theelectrode6 can fold and flex to substantially the same extent as themembrane34, even a region of themembrane34 not covered by an electrode layer, such that theelectrode6 does not impede the flexibility of themembrane34 or theelectrode assembly105. It should be appreciated that theelectrode6 can fold upon itself along with themembrane34, although folding can also occur between theelectrodes6. The ability to fold can allow for a lower device profile.
• The materials used to create theelectrodes6 can vary. Theelectrodes6 can be a thin film of an electro-conductive or optical ink. The ink can be polymer-based for better adhesion to the membrane. The electrode material can be a biocompatible, low resistance metal such as silver, silver flake, gold, and platinum which are additionally radiopaque. Inks may additionally comprise materials such as carbon and/or graphite in combination with the more conductive materials already described. The addition of carbon and/or graphite can increase the conductivity of the polymer matrix. When incorporated as fibers the carbon and/or graphite add additional structural integrity to the ink electrode. Other fiber materials may be substituted to attain the same end. When the electrode material is not particularly radiopaque, additives such as tantalum and tungsten may be blended with the electrode material to enhance radiopacity. An example of an electro-conductive ink is provided by Engineered Conductive Materials, LLC (ECM) which is a polyurethane-based silver loaded ink. Another example is Creative Materials Inc., which manufactures conductive inks, films, as well as radiopaque inks. As mentioned above, theelectrodes6 can be applied to themembrane34 andflex circuit89 using an adhesive. Alternatively, the electrode material can have adhesive properties or be an adhesive-loaded with conductive particles such as silver flakes such that theelectrodes6 can adhere the components of theflex circuit89 to themembrane34. If an additional adhesive layer is used to adhere theelectrode6 to themembrane34 andflex circuit89, the adhesive layer can include a conductive or non-conductive material. The electrodes formed with electro-conductive or optical ink or thin metal film can be visualized under fluoroscopy to provide a general sense of the shape of the membrane and location of the electrode. To enhance visualization under fluoroscopy, radiopaque additives can be included in the electrode material or radiopaque markers laid out next to, on top or below the electrodes as will be discussed in more detail below.
• The electrode material can be deposited using a variety of techniques known in the art including, but not limited to, printing, pad printing, screen printing, silk screening, flexography, gravure, offset lithography, inkjet, painting, spraying, soldering, bonding deposited using touch-less technologies or otherwise transferred onto the surface of themembrane34. In an embodiment, theelectrode6 can be formed by depositing an electrically conductive coating or layer by spraying a designated surface region. Alternatively, the electrode can be formed by depositing the electrically-conductive material onto a region of themembrane34 by vacuum deposition or printing the electrically conductive material on the designated surface region. This provides an electrically conductive coating of a desired thickness and a relatively uniform electrode through the desired area. Printing processes can include pad printing, screen printing and the like. Touch-free technologies such as positive material deposition of ink such as from a syringe or similar device can also be used to transfer conductive film or ink onto the membrane or substrates that are sensitive to pressure.
• The electrodes can also be made using thin, conductive adhesive film or gel that can be cut to the shape of the electrodes and serve as an adhesive for the flex circuit when conductivity is desired. The conductive adhesive gel can be mixed with conductive particles for conductivity and disposed over the substrate and UV cured.
• Each region of electrically conductive material can be deposited over and electrically connected to a specifiedconductive pad59 of theflex circuit89 and coupled to the surface of themembrane34. The electrodes can be formed by using a mask (chemical or mechanical) over the membrane during the deposition process, which can deposit electrode material over the membrane and the mask alike. Once the deposition process is completed, the masking can be removed as is known in the art. An alternate technique can be used where automated robotic systems are programmed to precisely and accurately spray only the desired electrode surfaces without the presence of a mask. This technique can have multiple movable axes such as the Engineering Fluid Dispensing Inc. dispensing robots (East Providence, R.I.).
• Theflex circuit89 components can be bonded before, during or after deposition of theelectrodes6 to themembrane34, for example, using an adhesive or thermal bond or the like as described above. The electricallyconductive layer96 of the flex circuitdistal branches87 can be exposed by etching away a portion of thedielectric layer100.
• The shape and pattern ofelectrodes6 created can vary. The surface area, shape and pattern of theelectrodes6 can influence the amount of energy applied and the ablation line created.FIGS. 5A-5I illustrate various electrode patterns and electrode shapes considered herein including, but not limited to, circular, rectangular, octagonal, polygonal etc. The shape and pattern of theelectrodes6 deposited on themembrane34 can be selected depending upon the intended application of the electrode assembly. A square electrode, for example, can be better suited for interpolation based on image projection analysis, such as to reproduce the shape ofdeployable membrane34 in a mapping and identification software algorithm. One or more rows ofelectrodes6 can be used. Each row ofelectrodes6 can have the same shape or can vary in shape and size. Spacing between theelectrodes6 within the same row or spacing between the rows can alter the depth and quality of lesion created. The rows of electrodes can have electrodes that line up or can be staggered as shown inFIG. 5D. Theelectrodes6 can be arranged in patterns that wrap around the flexible membrane structure to provide rings of electrodes as inFIG. 5A through 5F, or on “diagonals” such that when wrapped the electrode pattern will form helices. Patterns of electrodes may in addition be addressable by the RF power source individually as inFIG. 5G and others, or in groups as inFIGS. 5H and 5I. The electrode pattern may incorporate a single ring as illustrated inFIGS. 5A-5C, or they may incorporate two rows as inFIGS. 5D-5F, or they may incorporate more than two rows. Theelectrodes6 can also be deposited in a variety of other locations on thedeployable membrane34 as will be described in more detail below.
• Helical patterns of the electrodes have particular advantage when used to create lesions in body lumens, for example the pulmonary veins. In such situations there is a risk that if the lesions were created as a ring on a single plane normal to the long axis of the vessel or lumen, swelling of the lumen resulting from the ablative injury or the subsequent healing might stenos at a ring lesion. By wrapping the electrodes as indicated inFIGS. 18P and 18S the impact of any resultant stenosis associated with each lesion are not allowed to become additive. A single helical electrode energized in a monopolar fashion, or two helical electrodes spaced apart, as inFIG. 5G, may have advantages with regard to simplicity of the RF source, speed of application, and minimal fabrication costs. These configurations, however, have limitations when the uniformity of lesion, and the ability to modify the lesion in response to feedback acquired from sensing electrodes, to be described as described elsewhere herein, are primary to effective therapy.
• With reference to the uniformity of lesion, as the electrode surface increases the uniformity of tissue contact across the electrode can be lessened. This variation can be minimized by using a flexible electrode on a flexible membrane, also described elsewhere herein. However, as the surface area of the electrode grows, and or the aspect ratio for of the electrode increases, as in the long helical elements just described, the uniformity of contact become less controllable. As the contact area varies the current gradients and possibly total current delivered, depending on system design, will vary. Since the amount, and spacial distribution, of current transmitted to the tissue from the electrode control the size and depth of the resultant lesion, it is often more advantageous to use multiple smaller individually addressable electrodes. In addition to helical patterns of electrodes, rectilinear arrays may be used where the helical lesion pattern is created by addressing an appropriate pattern of electrodes, either individually or in pairs depending whether monopolar or bipolar energy is used. None helical patterns will have similar advantage to those stated for the helical pattern when their projection on a plane normal to the long axis of the lumen are continuous and closed, The spacing between electrodes is another important characteristic which can be used to control the volume of the lesion. As such, although not pictured, the present description anticipates various spacing and arrangements of addressability not specifically illustrated or described herein.
• FIG. 12 shows an embodiment of a pattern ofelectrodes6. The pattern shown inFIG. 12 is exemplary and variations in the pattern are possible. Current92 can be passed betweenadjacent electrodes6 and/or overlap anelectrode6 to reach thenext electrode6 to create the desired ablation line. Each of theelectrodes6 can be created as a solid pattern, a set of concentric circles or other geometric shape, or a set of lines intersecting or not. The surface area, shape and internal pattern of the electrodes can influence the density of the current and burn line created. These features can also affect the amount of current and power required as well as duty cycle and/or pulse wave modulation. There can be more than one row ofelectrodes6 to allow the user to actively select which region to use for creating the ablation lesion and avoid having to exactly position the device and or manipulate to create the proper ablation line. The ablation line can be created in a desirable location using techniques that are easy and fast and without the need for tedious repositioning.
• Themultiple electrodes6 deposited on themembrane34 can collectively create a large electrode array of energy-transmitting elements. This electrode array can form a variety of patterns across themembrane34 and has an energy-transmitting surface area. The electrode array pattern and energy-transmitting surface area can vary. In an embodiment, the energy-transmitting surface area covers at least about 10% of the membrane surface area to be selectively activated. In an embodiment, the energy-transmitting surface area can cover about 25% of the membrane surface area. In another embodiment, the energy-transmitting surface area can cover approximately 50% of the membrane surface area. The energy-transmitting surface area can be a factor of the physical surface area of each individual electrode within the energy-transmitting array as well as the projection of the expected ablation surface area based on the electrode pattern spacing. The preferred energy-transmitting surface area percentage can also vary depending upon the indication being treated. For example, for the treatment of atrial fibrillation the energy-transmitting surface area can cover at least 25% of the membrane surface to be selectively activated. In another embodiment, the energy-transmitting surface area can cover greater than 40% of the membrane surface to be selectively activated. These percentages are provided for example and can vary. The large energy-transmitting surface area allows the membrane surface to selectively ablate more tissue simultaneously without the need for repositioning. Generally, the lesion site can be slightly larger than the energy-transmitting surface area.
• Eachelectrode6 can also be a grouping of multiplesmaller electrodes51 such as the embodiments shown inFIGS. 6A-6B. Each of thesmaller electrodes51 can be connected by the conductive traces16 of theflex circuit89 as shown inFIG. 6B to form alarger electrode6. Alternatively, thesmaller electrodes51 can be independently activated for mapping electrical signals as may be needed in some indications such as the treatment of atrial fibrillation. Thetraces16 can be created as a sinusoidal line, for example, to allow for some elongation of the expandable element so that the individual electrodes can spread farther apart and the electrodes become substantially larger. As shown inFIG. 6B, traces16 allow for uniform elongation in all directions. Alternatively, thetraces16 can allow for elongation in specified directions. The surface area, shape and pattern of the electrodes can influence the amount of energy transmitted to the target tissue. Measurement withsmaller electrodes51 can provide higher resolution and accuracy of the signal location, which can be useful for example in mapping aberrant signals.FIG. 6C illustrates an embodiment of anelectrode6 that includes asmall electrode51 located at the center of thelarger electrode6. Each of the electrodes is connected to their individual traces16. This embodiment can be used to confirm conduction block such as during treatment of atrial fibrillation by comparing conductivity before and after ablation or by moving the electrode structure further into the pulmonary vein for measurements.FIG. 6D illustrates an embodiment of anelectrode6 configured as a dual spiral with the inner ends merged. This embodiment can be used when the resistance of the electrode is required to be monitored such as when the electrode is used as a temperature sensor in conjunction with its electrode function as discussed elsewhere herein. In such a configuration the long path of the trace forming the electrode is contained in a small area. Arranging the electrode as a long path allows changes in the resistance as different areas of the electrode have comparable effects on the overall resistance of the electrode.
• Theelectrode6 can be a thin, flexible film that is deposited over a portion of theflex circuit89 as well as a portion of themembrane34. As discussed briefly above and shown as an example inFIGS. 7A-7E, each of theelectrodes6 has dimensions that exceed those of theconductive pad59 or theconductive trace16 of theflex circuit89 such that theelectrode6 covers an area of themembrane34 on which theflex circuit89 is mounted.FIG. 7A shows thesubstrate layer52 of theflex circuit89 following and outlining the conductive traces16. Theelectrodes6 can extend beyond thesubstrate layer52 onto the underlyingmembrane34 to provide a large surface for theelectrode6 to contact the tissue. This is in contrast to many devices known in the art which use the small, non-insulated portion of the flex circuit itself as the electrode element. Larger surface area and biggeroverall electrodes6 allow theelectrode assembly105 of the devices described herein to transmit energy deeper and with less risk of gaps in the energy transmission line. To increase the durability of theelectrodes6, thesubstrate layer52 can be extended over portions of theelectrodes6. This can restrict elongation on sections of the membrane where theelectrodes6 are located and can ensure, for example predictable ablation lesion size and quality.FIG. 7B shows thesubstrate layer52 can extend to outline the shape of theelectrodes6 to be deposited.FIG. 7C shows thesubstrate layer52 can have finger-like extensions or struts that can extend to the edge of theelectrodes6. A combination of any of the above can also be used.
• The dimensions of theelectrode6 can vary. In an embodiment, eachelectrode6 can be between about 0.015 to 0.050 mm in thickness. In an embodiment, eachelectrode6 is less than 0.025 mm in thickness. In an embodiment, eachelectrode6 can have an overall surface area of between 3 and 36 mm2. In an embodiment, eachelectrode6 can have a size that is approximately about 2 mm round. In comparison, eachconductive trace16 can be between about 0.05 mm and 0.10 mm in width and between about 0.02 and 0.05 mm in thickness. Eachconductive pad59 can be between about 0.05 and 0.70 mm in width and between about 0.02 and 0.05 mm in thickness. In an embodiment, eachconductive pad59 can have an overall surface area of between about 0.002 and 0.450 mm2. In an embodiment, theconductive pad59 can be approximately 0.5 mm round. It should be appreciated that the aforementioned dimensions are exemplary and that variations are possible.
• The relative dimensions of theelectrode6 and portions of theflex circuit89, such as theconductive pad59, can also vary. In an embodiment, the surface area of eachelectrode6 as it relates to the surface area of its associatedconductive pad59 can be described in terms of a ratio and can be at least about 14:1. In another embodiment, the ratio of electrode width to conductor width can be about 13:1. The relative dimensions between the electrode assembly components can also vary depending upon the indication being treated. For example, atrial fibrillation-specific devices the ratio of surface area ofelectrode6 to surface area ofconductive pad59 can be at least about 44:1. Theconductive pad59 can be approximately 0.5 mm round and the electrode can be a minimum of approximately 3×3 mm or 3.4 mm round for a 44:1 ratio. For an electrode having an area of 4 mm round, the ratio can be approximately 62:1. For an electrode having an area of 5 mm round, the ratio can be approximately 95:1. For an electrode having an area of 3×5 mm, the ratio can be approximately 74:1. For an electrode having an area of 5×5 mm, the ratio can be approximately 123:1. In another embodiment, the ratio of electrode width to conductor width on the flex circuit can be approximately 35:1. The conductor width can be 0.07 mm and a minimum width of the electrode can be 3 mm for a 3×3 mm electrode. In another embodiment, the electrode can have a surface area of at least about 9 mm²(3.4 mm round) and an electrical conductor of between about 0.025 to 0.050 mm maximum thickness. This combination results in a flexible electrode that has a large surface area yet is connected to a very thin conductive trace. It should be appreciated that the aforementioned relative dimensions are exemplary and that variations are possible.
• The energy delivered by theelectrodes6 can vary. The energy can include direct current (DC), alternating current, radiofrequency (RF) energy, for example in a monopolar or bipolar energy configuration, microwave, high voltages. When using RF and or high voltages the energy levels can be adjusted to cause thermal damage by increasing the tissue temperature to above 42° C. or by creating high voltage gradients to bring about irreversible electroporation (IRE). Microwave and RF energy can use the application of thermal energy for cell necrosis while IRE can use high voltage electrical pulses to create cell permeability leading to cell death. Voltage energy can be delivered in very high voltage dosage in short bursts. Use of bipolar RF energy prevents the current from traveling through the bloodstream and reduces the risk of charring and thrombus. Bipolar energy also removes the effect of blood flow on the energy delivery compared to monopolar and generally provides more consistent results. Theelectrode assembly105 can be used exclusively in the bipolar configuration without using the monopolar configuration to minimize or eliminate current transfer through the bloodstream. The energy applied during an energy transmission period can be in the form of high energy and low energy cycles (on/off) or alternating high and low temperatures.
• FIG. 8 illustrates an embodiment of the flex circuitry wiring for theelectrodes6. Eachelectrode6 can be connected to anRF amplifier48. Eachelectrode6 can be individually turned on and off for monopolar or bipolar energy transmission. For monopolar, theelectrodes6 can be connected via amonopolar bus line14 to apatient return electrode13 and can be individually or simultaneously activated by switches37. For bipolar, theelectrodes6 can be connected via a bipolar bus line73 and can be individually or simultaneously activated by switches37. Variations in the manner of connection between the electrodes are possible. As will be discussed in more detail below,temperature sensors90 can be included in theelectrode assembly105 and can share an RF conductive trace with anadjacent electrode6. This allows for dual use of the conductors which reduces the overall bulk and profile of the device. It also eliminates the need for an additional assembly junction on the membrane during manufacturing and allows for a narrower flex circuit and lower profile. It should be appreciated that theelectrodes6 can also be used for mapping as will be discussed in more detail below.
• Theelectrodes6 can include a variety of activation mechanisms.Multiple electrodes6 can be individually connected to asingle flex circuit89 and can be individually controlled and individually activated for a more precise energy transmission via an electronic control box. Alternatively, theelectrodes6 can have a physical movable activation means, such as a conductive wire, which can be electrically connected to an array of electrodes in series.FIGS. 9A-9B, for example, show aconductive trace16 that can be a movable wire housed within a lumen33. Thetrace16 can contactindividual electrodes6 located in series and activate them individually or in unison. This can allow a user to create a burn pattern precisely where needed without having to move themembrane34 to a different position.FIG. 10 shows another embodiment of a selective activation mechanism which includes anelectrode sleeve10. Aconductive trace16 can be advanced distally or withdrawn proximally within a lumen of theelectrode sleeve10. The distal end of theconductive trace16 can have a region of exposedconductive layer96 covered by anelectrode6 that can selectively contact the tissue to be ablated through theopenings32 of theelectrode sleeve10. This configuration can allow the user to position the electrode device once and tune the position of theelectrodes6 with the least amount of manipulation. This minimizes the amount of risk of trauma and injury to the patient as well as reduces the time of the procedure.FIG. 11 shows an embodiment in which theelectrode sleeve10 havingmovable traces16 is mounted to a surface of amembrane34 such as a balloon.
• Theelectrodes6 described herein can have low thermal mass or inertia for quick heating and quick heat dissipation. This low thermal mass provides a more consistent and predictable temperature and energy delivery as well as a more accurate measurement of temperature and better user control of the energy. One ormore temperature sensors90 can be mounted directly on theflex circuit89 adjacent or over theelectrodes6 to provide feedback during use of tissue temperature such that power, current, duty cycle can be modulated and maintained within a specified temperature or temperature range. Thetemperature sensors90 considered herein can include surface mount thermistors, thermocouples or other resistance temperature detectors or platinum resistance thermometers. Thetemperature sensor90 can be bonded to theconductive trace16, for example, with an adhesive.
• The number and pattern oftemperature sensors90 included in eachflex circuit89 can vary.FIG. 12 shows an embodiment of anelectrode6 andtemperature sensor90 pattern where the temperature sensor is located between twoelectrodes6, between fourelectrodes6 or in contact with oneelectrode6.FIGS. 13A-13B show other embodiments of an electrode assembly including adistal branch87 and branchingconductive traces16 of aflex circuit89 contactingmultiple electrodes6 and atemperature sensor90. Eachelectrode6 can be connected to oneconductive trace16 stemming from thedistal branch87. Thetemperature sensor90 can share theconductive trace16 with theelectrode6 and be positioned near where theelectrode6 is touching the tissue. For example, atemperature sensor90 can have a common ground and each end can be connected to one of theelectrodes6 and switched/multiplexed with RF power. The dual usage for thetrace16 betweentemperature sensors90 andelectrodes6 reduces the overall profile of theelectrode assembly105. Fewer connections results in less material and less bulk of the device, better packing and ease of manufacture.
• The electrodes may be configured to provide the temperature sensing function thereby replacing some or all of the temperature sensors described herein. Such configurations include using the inherent temperature coefficient of resistance (“tempco”) of the electrode as a means to characterize the electrode temperature. Conductive ink ECM CI-1036 configured as a 0.3 mil thick electrode demonstrates a linear tempco of 0.005 ohms/degree C. over the range of 30 to 60 degree C. This is very close to the 0.006 ohms/degree C. associated with silver. Copper or aluminum with temperature coefficients approximately 0.004 ohms/degree C. coated with silver or gold to protect the electrode and improve biocompatibility are additional material useful for such temperature sensing electrodes. Platinum with a tempco of approximately 0.004 ohms/degree C. is yet another material useful for such purposes. These materials may be used in any of the other electrode configurations described herein. Alternatively the electrodes may be comprised as a conductive ink modified to have a nonlinear tempco within the desired temperature control range and exhibiting a large change in tempco at a predetermined control temperature with in this range. In such configurations the size, shape, loading, and composition of the conductive particles and the matrix polymer may be adjusted to create such a transition. In particular, as the matrix expands at the rate associated with its coefficient of thermal expansion, the overlap and contact area between particles is abruptly reduced, thereby abruptly increasing the electrical resistance. In such configurations the electrode can act as its own temperature regulator.
• In configurations using the electrode as a temperature sensor the return line associated with the separate temperature sensors may be used as a return line for measuring the temperature of the electrode. The return line can be gated in such a fashion that it is an open circuit when delivering RF and a closed circuit during a measurement period. Alternatively the temperature sensor has a very nonlinear tempco within the control range; a return line is not required. In this situation the inherent increase in resistivity of the electrode when used as a temperature sensor, or that of an ancillary temperature sensor when in use, may be used to limit the delivery of RF energy after a control temperature maximum has been attained.
• The location, distribution throughout theflex circuit89 and number oftemperature sensors90 incorporated with theelectrode assembly105 can vary. In an embodiment, thetemperature sensors90 can be adjacent, directly covering, or in between theelectrodes6.FIG. 7A shows atemperature sensor90 located in between twoelectrodes6. In a non-limiting example, thetemperature sensor90 can be generally less than 1 mm away from theelectrode6. The trace connected to thetemperature sensor90 can be shared with thetrace16 for theadjacent electrode6.FIGS. 7D and 7E shows an embodiment of anelectrode assembly105 where thetemperature sensor90 is located at the center of anelectrode6 instead of between two electrodes. Thetemperature sensor90 may be electrically isolated from theelectrode6. One ormore temperature sensors90 can be used per pair ofelectrodes6. In an embodiment, at least 10temperature sensors90 can be included for temperature control.
Deployable Membrane
• Theelectrode assembly105 also includes a deployable,flexible membrane34 to which theflex circuit89 andelectrodes6 can be coupled. When deployed, themembrane34 can deliver energy through the large surface area of theelectrodes6 to a target tissue. The deployedmembrane34 andelectrodes6 can ablate tissue over a large zone or area in a variety of patterns, for example circumferential, curved and linear patterns, as will be discussed in more detail below. Despite the large overall surface area of themembrane34 covered by theelectrodes6 and theflex circuit89, themembrane34 can be readily conformable to the target tissue to be ablated and also compactly folded into a small diameter such that theelectrode assembly105 can be delivered, for example, through small access channels for minimally-invasive delivery.
• The structure of themembrane34 can vary including, but not limited to a membrane sheet, cylinder, tube, inflatable, expandable, or fellable structure, such as a balloon, or braided mesh and the like. In an embodiment, the electrode assembly includes a deployable membrane that is formed into a linear structure or a cylindrical tube such as acylindrical electrode element34 as shown inFIGS. 16A-16B. Thecylindrical membrane34 can havemultiple electrodes6 deposited along its length in varying patterns. Themembrane34 can be steered and manipulated, for example to ablate two anatomical regions simultaneously. Themembrane34 can include sections of varying flexibility and stiffness for the ability to steer. The distal end of themembrane34 can be manipulated with aguidewire40 for proper placement at or near thetarget tissue80, for example into a vessel such as the pulmonary vein for the treatment of atrial fibrillation. A region of themembrane34, for example a middle region, can be highly flexible such that by pushing a handle (not shown) distally the middle region of themembrane34 can bend and be directed toward another anatomical region, for example such as inserted into an adjacent vessel (FIG. 16B). This can be useful, for example, when ablating a region between the two pulmonary veins that can have highly irregular anatomy that is difficult to access. Themembrane34 can also be inflated or expanded to contact thevessel wall83 and anchor the device in place as will be discussed in more detail below. Thecylindrical electrode element34, which is located on theelectrode catheter71, can be advanced through asheath65, such as a transseptal sheath (seeFIGS. 15A-15B). The user can control the distal end of theelectrode sheath76 via apull tether70 at the proximal end of theelectrode catheter76. Pulltether70 can be concentric and housed within theelectrode catheter76 in some portion more proximal than what would be protruding from thetransseptal sheath65.
• In one embodiment, theelectrode catheter71 can be housed within anelectrode sheath76 as shown inFIGS. 14A-14B. In an embodiment, one ormore electrodes6 can be positioned on an outer surface along the length of theelectrode sheath76. Theelectrode catheter71 can be used in conjunction toelectrode sheath76 to transmit thermal energy in multiple locations. In another embodiment, theelectrode sheath76 can slide over asteerable guide catheter47 anchored in place, for example using ananchoring basket50 or a suction tip18 at the end of an anchoring catheter15 to anchor onto neighboring tissue such as the myocardium near thepulmonary vein80. Thesteerable guide catheter47 can be used to position theelectrode sheath76 to produce the desired treatment lines81. It should be appreciated that theelectrode sheath76, theelectrode catheter71 and steerable guidecatheter47 can be incorporated into a single catheter configuration.
• Themembrane34 of theelectrode assembly105 can have an expandable structure (self-expanding or otherwise) that can place the electrodes in full contact with tissues. Themembrane34 of theelectrode assembly105 can have an expandable structure that is closed or fluid-tight, such as a balloon or a cylindrical tube. Themembrane34 of theelectrode assembly105 can also span or have an expandable structure that is open, such as a woven, braided, stent or basket-like expandable structure as shown inFIG. 17A-17D. In an embodiment, theexpandable structure93 can radially expand to an open state (self-expanding or user-operated). Theexpandable structure93 can be surrounded by theelectrode assembly105 such that the flexible,outer membrane34,flex circuit89 andelectrodes6 are disposed thereon. Theexpandable structure93 can be attached to acatheter57 viadistal support elements44. In one embodiment theflexible membrane34 can surround theexpandable structure93 while attached by sutures at the intersections of thedistal support elements44 and theexpandable structure93. In another embodiment, themembrane34 may be weaved through some or all the loops of theexpandable structure93 while allowing sufficient material for elongation and movement of theexpandable structure93. The electrodes (not shown) can also be mounted over a single wire or over the intersection of wires or both. Theexpandable structure93 can be flexible and conform to a variety of anatomical shapes.FIG. 17A shows theexpandable structure93 in a relatively elongated state with a lower profile more suitable for insertion and removal through a small access channel or sheath. FIG.17B shows theexpandable structure93 in its fully expanded state that can be used or is suitable for energy transmission. A guidewire (not shown) can be used when ablating, for example around the pulmonary vein. When the guidewire is retracted, the distal end of theexpandable structure93 can be used to ablate tissue.FIGS. 17C and 17D show close-up views of an embodiment of the woven loops of theexpandable structure93. Theexpandable structure93 can be a shape memory material such as Nitinol.
• In another embodiment, shown inFIGS. 17E-17G, acatheter57 can have one or more electrodes disposed on an expandable structure. The configuration of the expandable element can vary including a flat wire or coil. Once deployed the diameter of theelectrode6 can be larger than the diameter of thecatheter body57. This promotes optimum contact with thetissue83 to be ablated or mapped. Additionally, these “spring” electrodes can be constructed for self-adjustment within their range of movement to conform to a variety of anatomies. A pressure or movement sensitive mechanism can be incorporated at each electrode in order to provide feedback to the user about tissue contact prior to device activation. Aflexible membrane34 can also be placed over these spring elements with the electrodes disposed on the membrane.
• Theflexible membrane54 can be disposed around anexpandable structure98 that is self-expanding such as a braid, coil or the like, as shown inFIGS. 60A-60D.Electrodes6 may be arranged over the tubular thinwalled membrane54. Asheath31 can cover the electrodes and support structure for a low profile delivery. Once inside the desired location, the sheath can be pulled back, exposing thestructure98 and theelectrodes6. Themembrane54 can be attached to one or both ends of thesupport structure98. An exemplary benefit of this approach is that the device does not occlude the anatomy during ablation. The structure is open through its longitudinal length and thus allows for the flow of fluid or gas. This eliminates a concern especially when treating blood vessels. The membrane can also include holes, slits, or ports which allow for additional fluid or gas passage to minimally interfere with anatomical flows.
• FIGS. 60A and 60B show an embodiment of this design. Thestructure98 is directly attached to thecatheter shaft57 which creates a funnel shape at the junction of the shaft and the structure. This facilitates sheathing and unsheathing of the structure.FIG. 60C shows another embodiment in which acoupling element60 connects theshaft57 and thestructure98, which allows for full expansion of thesupport structure98 at the distal and proximal end and thus fully expansion of the electrode-carryingmembrane54. A depiction of the flow of blood is indicated with arrows inFIG. 60C.FIG. 60D illustrates athin wall membrane54 withelectrodes6 supported by acoil support structure98. This embodiment allows for a very small profile in that a coil can be sheathed into an essentially linear structure. To prevent distortion of the electrodes, themembrane54 in this particular embodiment may be attached at only the proximal end or otherwise contain compliant sections not directly affecting the electrodes during sheathing.
• The electrode assembly can include a perfusion balloon and catheter configuration in which blood flow is not restricted by the presence of the device. The assembly can include a large inner lumen which allows the use of a guidewire and is large enough to also accommodate for flow of fluid, such as blood.FIG. 18G illustrates one such embodiment. The flow of blood indicated by arrows can enter the guidewire lumen and exit a hole110 that can be located just proximal to themembrane34 on theshaft57.
• Themembrane34 of theelectrode assembly105 can also have a closed, expandable structure, such as a balloon as shown inFIGS. 18A-18M. Themembrane34 can have an expandable structure that is fluid-tight such that it can be filled with a liquid or gas to expand or inflate it. The membrane can be expanded using a variety of techniques such as by filling with a gas or liquid, such as saline, a radiopaque dye, cooling fluid, blood-safe gas and the like. The expandable structure can also be self-expanding. Themembrane34 can be covered bymultiple electrodes6 and can be coupled near its proximal region to a distal end of acatheter57. The distal and proximal regions of themembrane structure34 shown inFIGS. 18A-18C protrude outwards forming smaller domes, which can provide convenience for manufacturing.FIGS. 18D-18M illustrate other embodiments of anelectrode assembly105 where themembrane34 has a continuous smooth surface and no protrusions or domed regions at its distal and proximal end regions. The distal end of themembrane34 can be flat or as shown inFIGS. 18F and 18G drawn into itself creating a concave surface at its distal end. The surface of the membrane can be that portion of the membrane that is expandable upon introduction of fluid and that typically expands from proximal and distal points of attachment to the catheter body.
• FIGS. 18I-18M show various views of an embodiment of thedeployable membrane34 of theelectrode assembly105 that has a fluid-tight expandable structure. Thedeployable membrane34 can havemultiple electrodes6 electrically connected via one ormore flex circuits89. As shown inFIG. 18I, eachflex circuit89 can be routed through theshaft57 and can exit or emerge from the inner diameter of themembrane34 at a distal end region and split into two at a Y-junction. This allows asingle flex circuit89 to be positioned at different latitude positions on amembrane34.FIG. 18J shows an embodiment of theconductive pad59 that can be used to electrically connect theelectrodes6.FIG. 18K shows an embodiment of amapping electrode51 that is smaller and in between thelarger electrodes6.FIG. 18L shows an embodiment of the distal end region of themembrane34 that can be drawn into itself creating a concave surface.
• The flex circuit shown and described with reference toFIG. 3E can be seen inFIGS. 18N and 18O incorporated into a deployed electrode assembly at the end of ashaft57. The circuit includes an intermediate portion with a plurality of branches separated along their lengths. In thisembodiment branches87 are equally spaced from adjacent branches along an equator defined by the toroid-shapedmembrane34 in the expanded configuration shown. The branches are affixed in a uniformly distributed fashion around the equator of the toroid-shapedmembrane34 in the expanded configuration shown. The branches are flexible and conform tomembrane34. Three rings ofelectrodes6 can be seen, a single ring electrode at the distal end of the expandable member interfaced withconductive pad59c(shown in other embodiments herein), a ring of ten individual electrodes interfaced withconductive pads59b(shown in other embodiments herein), and an additional ten electrodes interfaced withconductive pads59a(shown in other embodiments herein). The device also includesthermistor elements90 interposed between electrode elements interfaced with the conductive pads.
• InFIGS. 18N and 18O, the branches are coupled to the membrane such that they conform to the membrane and are uniformly spaced from one another in the membrane's expanded configuration. In an end view of the expanded device (looking in the distal-to-proximal direction), at least two adjacent branches define an angle greater than 30 degrees. In some embodiments at least two adjacent branches can be separated by more than about 10 degrees. In some embodiments at least two branches are separated by more than about 90 degrees. In alternative embodiments the branches are not uniformly spaced from one another, such that two branches define a first angle and two branches define a second angle, wherein the first angle is different than the second angle.
• The branches are flexible, allowing them to conform to the radially outer surface of the membrane inFIGS. 18N and 180. The branches extend substantially 360 degrees around the longitudinal axis of the shaft and are uniformly spaced from one another.
• InFIGS. 18N and O the plurality of branches of the intermediate portion are fixed on the expandable membrane and the membrane maintains the separation between the branches. The configuration of the expandable membrane can at least partially define the angles between the branches of the intermediate portion and/or the orientation of the branches on the membrane.
• In some embodiments at least three branches terminate in a connector at the proximal end of the flexible circuit.
• In the embodiment inFIGS. 18N and O portions of the branches are folded by selective orientation on the flexible expandable membrane.
• Theflex circuit89 can wrap around themembrane34 to power the electrodes as shown inFIG. 18J. Theflex circuit89 can extend to the proximal end of themembrane34 and/or into the distal end of theshaft57 as shown inFIG. 18M. Extending the flex circuit to the joint where theshaft57 and themembrane34 meet can increase the robustness and ease of manufacturing theelectrode assembly105. The flex circuit main leads can be inserted within the inner diameter of the shaft and bonded in place. This can be beneficial for preventing de-lamination of the flex circuit main leads17, such as during the sheathing process. These sections of theflex circuit89 can power another set of electrodes located at or near the proximal end of themembrane34. With a toroidal-shaped,closed membrane34, the location of theelectrodes6 face away from the distal portion of themembrane34, such that they face in a proximal direction towards theshaft57 of theassembly105. This configuration can be useful in reaching target tissues that are located directly through an access point, such as for example the septum once a catheter crosses the septum to enter the left atrium.
• The shape of theexpandable membrane34 can vary including, but not limited to, cylindrical, spherical, toroid, doughnut-like, conical, branched, pronged and other geometries. As shown inFIGS. 18D-18M, theexpandable membrane34 has a toroid shape. This shape provides for better maneuverability of the distal tip due to the relatively short longitudinal length of the structure. A cylindrical shapedexpandable membrane34 incorporated inelectrode assembly105 is illustrated is illustrated inFIGS. 18P through 18S. InFIG. 18P thedistal branches87 offlex circuit89 have a configuration similar to that illustrated inFIGS. 3D and 3F, where the distal branches are longer to accommodate the cylindrical shapedexpandable membrane34. An alternative configuration to the longitudinally orienteddistal branches87 offlex circuit89 is shown inFIG. 18S. In this configuration the distal branches are wound about the cylindrically shapedexpandable membrane34. Note that inFIG. 18S only the substrate layer of theflexible circuit89 have been illustrated, but all of the features associated with the other flex circuits herein described can be incorporated in the flex circuit ofFIG. 18S. The electrode assembly of18P can be populated such that an electrode is associated with any combination of locations indicated by the irrigation holes shown. Using such an electrode assembly, a number of helical lesion patterns of different orientation and pitch can be created specific to the particular luminal site under treatment, without the need to reposition the electrode structure.
• FIG. 18H illustrates the swiveling action the toroid shaped membrane structure can achieve. Because the longitudinal length of the membrane structure on the catheter shaft is relatively short, the membrane structure can move relative to the shaft without bending the shaft. When the membrane structure is used in a semi-inflated state, this allows for greater motion or swiveling of the membrane structure on the shaft. Further, asmaller membrane structure34 can be used, which although it may be subject to more frequent manipulation of theelectrode assembly105 during the procedure it can allow for easier manipulation especially in smaller and/or tight anatomies. Electrode assemblies havingsmall membrane structures34, such as shown inFIGS. 22A to 22B andFIGS. 26A to 26C, can be useful for touch-ups during the procedure or during follow-up procedures.
• Thedeployable membrane34 can have an expandable structure that is symmetrical such as shown inFIG. 19A. Theelectrodes6 can be evenly distributed across themembrane34 where they can be connected to their individual conductive traces16 stemming from the distalflex circuit branches87. Thedistal branches87 connect to the main flex circuit leads17 (not shown) which can be routed through thecatheter57 such that they can connect at a proximal region for example at a handle. Thedeployable membrane34 can also have an asymmetrical configuration as shown inFIGS. 19B and 19C. An asymmetrical structure can reduce bulk and can allow for easier manipulation and positioning of electrodes.FIG. 19C shows the asymmetrical membrane structure conforming totissue83 such as the pulmonary vein. In atrial fibrillation applications, for example, thedeployable membrane34 having an asymmetrical structure can involve two or more different applications of energy and rotations of themembrane34 to completely isolate the pulmonary vein. The asymmetrical structure can allow for better rotation control and placement of theelectrodes6 against thetissue83.
• Theelectrode assembly105 can include anenclosed membrane34 and can be of any shape or form, one of which can be a cylindrical shaped balloon. Themembrane34 can further be shaped to maintain a curved position or include one or more pull wires.FIGS. 19D-19F show alternative embodiments for amembrane34 for anablation assembly105 including one that has a flat distal end surface and one that is more conical. It should be appreciated that other variations of the membrane shape can be possible. The length of themembrane34 can be shorter or longer and the shape can be straight or contain any amount of curvature. Theelectrode assembly105 can include aflex circuit89 which powers one ormore electrodes6. Theelectrodes6 can be laid out in an asymmetrical pattern ofelectrodes6 on the inside of the curve versus the outside of the curvature. The distal end of themembrane34 can also include a singlelarge electrode6 as shown inFIG. 19F.Fiber optic scopes38 can be included to theelectrode assembly105 as well as shown inFIG. 19D.
• The shape of themembrane34 can be changed or adjusted before, during or after use.FIGS. 20A-20C show an embodiment of anelectrode assembly105 having adeployable membrane34 that can be expanded into a balloon shape. Thedeployable membrane34 is coupled at an outer surface of its proximal region to supportarms44 extending from the distal end of thesteerable catheter57. The membrane is coupled at its distal region to ashaft46 that extends through and translatable relative to thesteerable catheter57. Theshaft46 can translate from a proximal position in which themembrane34 is folded distal to thecatheter57 andshaft46. Theshaft46 can also translate to a distal position in which themembrane34 expands into an enlarged structure and exposes the most distal electrodes suitable for energy transmission as seen inFIG. 20B. The shape of themembrane34 can be varied depending upon the position of theshaft46 relative to thecatheter57. For example, themembrane34 can have a fully rounded configuration as shown inFIG. 20B or a distally flattened configuration such as shown inFIG. 20A or a distally concave configuration as shown inFIG. 20C or anywhere in between. This allows for positioning and exposure of the electrodes as needed to fully contact the target tissue.
• Themembrane34 andelectrode assembly105 can conform to three-dimensional anatomy for optimum tissue contact and energy transmission. Good apposition of the membrane allows for better contact of theelectrodes6 to the surface of the tissue. Themembrane34 having an expandable structure as described above can be expanded to a variety of conformations, shapes and have a range of diameters over a relatively low range of pressures. In an embodiment the membrane can be radially expanded such that it fits and conforms within two regions of the anatomy simultaneously (for example seeFIG. 16B). In another embodiment, themembrane34 can have a large distal diameter (for exampleFIGS. 18A-18M) and/or can be tapered, or funnel-shaped (for exampleFIGS. 20A-20C). This allows for a better conformation to circumferential geometries, for example regions near the ostia of a pulmonary vein.
• FIGS. 21A-21E illustrate how amembrane34 having an expandable balloon-type structure can conform totissue83 having a variety of anatomical shapes. Themembrane34 can be semi- or non-compliant, but can still conform to target tissues depending the degree to which it is filled. In an embodiment, thedeployable membrane34 can be non-compliant and have an expandable, closed structure that is only partially filled. Partial filling of a non-compliant, closed structure can allow it to properly conform to the target tissue despite the non-compliant properties of the membrane material itself. In another embodiment, thedeployable membrane34 has an expandable, closed structure and a relatively short longitudinal length. In this embodiment, partial filling of the structure such as with a fluid, gas or liquid results in a conformability and swiveling steerability. Themembrane34 can have an expandable, closed structure that is branched or can split into two branches at its distal end upon expansion. In the expanded state,electrodes6 on each of the branches can be in contact with thetissue83 during energy transmission (seeFIG. 21E). The pronged or two-leg shape can aid in reaching irregular surfaces between, for example two vessels such as the carina between thepulmonary vein80.
• As described above, theelectrodes6 can be deposited on themembrane34 as well as on a portion of theflex circuit89. Themembrane34 can includemultiple electrodes6 or themembrane34 can have asingle electrode6 covering a portion or theentire membrane34. For example,FIG. 22A shows amembrane34 havingmultiple electrodes6.FIG. 22B shows asingle electrode6 covering a distal portion of themembrane34.FIG. 22C shows asingle electrode6 that surrounds the entire outer surface of themembrane34. Further, themembrane34 can be impregnated with conductive material which then can become the electrode. It should be appreciated that the size of themembrane34, in particular an enclosed membrane such as the balloon shape shown inFIGS. 22A-22C, can be of any size and shape. A small balloon size can be used for treatment of small anatomical sites or for touch-up/follow-up secondary treatments.
• In addition to the variation in the number ofelectrodes6 deposited on themembrane34, the location and pattern of electrode deposition can vary as well. For example, as shown inFIGS. 18A-18C theelectrodes6 can be positioned on a section of themembrane structure34 having the largest diameter upon expansion. The distal domed region can includeelectrodes6 for the purpose of mapping, sensing, stimulating and/or ablation.FIGS. 18D-18M illustrate other embodiments of themembrane34 havingelectrodes6 positioned circumferentially from the largest diameter section of themembrane structure34 to the flat region at the distal end. As another example, in the treatment of atrial fibrillation the electrodes can be positioned on the membrane structure to optimize contact with the antrum of the ostium. Theelectrodes6 can also be placed at the proximal end of themembrane34 as shown inFIG. 18M to ablate or map structures in anatomical locations such as the septum as described above.
• The materials of themembranes34 described herein can vary. Generally, the membrane material is thin, readily foldable into a low profile and refoldable after expansion. The materials can be elastic, inelastic, stretchy, non-stretchy, compliant, semi-compliant, or non-compliant. In an embodiment, themembrane34 has an expandable structure and can be constructed of materials such as those materials used in the construction of balloon catheters known in the art, including, but not limited to polyvinyl chloride (PVC), polyethylene (PE), cross-linked polyethylene, polyolefins, polyolefin copolymer (POC), polyethylene terephthalate (PET), nylon, polymer blends, polyester, polyimide, polyamides, polyurethane, silicone, polydimethylsiloxane (PDMS) and the like. Themembrane34 can be constructed of relatively inelastic polymers such as PE, POC, PET, polyimide or a nylon material. Themembrane34 can be constructed of relatively compliant, elastomeric materials including, but not limited to, a silicone, latex, urethanes, or Mylar elastomers. Themembrane34 can be embedded with other materials such as for example, metal, Kevlar or nylon fibers. Themembrane34 can be constructed of a thin, non-extensible polymer film such as polyester or other flexible thermoplastic or thermosetting polymer film. In one embodiment theflexible membrane34 can be 0.001″ to 0.002″ in thickness to provide sufficient burst strength and allow for foldability. In some embodiments it is preferable to have the electrode mechanical properties as close to the membrane mechanical properties as possible. One way of providing this is to use an inelastic membrane that will not stretch as it is expanded. This helps secure the branches to the membrane.
Low Profile Folding and Delivery Conformation
• The electrode assemblies and devices described herein incorporate a design and structure that are optimized for low bulk and low profile folding. The electrode assemblies and devices described herein can be used, for example in minimally-invasive delivery of energy transmission to tissues. The construction of the electrode devices, such as the routing of the flex circuit main leads through the device, also can contribute to the low bulk and low profile of the device.
• Adeployable membrane34 having an expandable structure can be mounted at a distal end of acatheter57 configured for percutaneous delivery (seeFIGS. 23A-23H). The flex circuit main leads17 of theflex circuit89 can extend from a handle (not shown) and be routed through an inner lumen of thecatheter57. The flex circuit main leads17 can emerge out of the inner lumen of thecatheter57 as well as the inner diameter of thedeployable membrane34 at a distal end region as shown inFIGS. 23A and 23B. Alternatively, the flex circuit main leads17 can emerge from a proximal end region as shown inFIG. 23C-23H. The flex circuit main leads17 can be kept together until they emerge out of thecatheter57 where they may branch out into their respectivedistal branches87. Thedistal branches87 can immediately branch out into multipleconductive traces16, which can be attached to an outer surface of themembrane34. Other configurations of the flex circuit main leads17 anddistal branches87 are possible, thedistal branch87 can continue to the distal tip of the balloon for example.
• During manufacturing, themembrane34 can be mounted on a temporary mandrel support having inflation ports to maintain a constant expanded state during assembly. The flex circuit can have branches with sacrificial tabs102 (seeFIGS. 3A and 3B) that can be mated to an assembly fixture for consistent tensioning of all branches of theflex circuit89 during assembly. Adhesive can be applied to the inner surface of the flex circuit that will be in contact with themembrane34. This can be accomplished through the use of a robotic system that can apply precise volume of adhesive and precise locations on the flex circuit. The main leads17 of theflex circuit89 can exit at or near the distal end of theshaft57 or the proximal end of theflexible membrane34 and extend distally (seeFIGS. 23C-23H).Electrodes6 can be positioned at or near the distal end of themembrane34. They can be positioned as two distal-most electrodes for each branch of the flex circuit as shown inFIGS. 23G-23H. It should be appreciated that theflex circuit89 and theelectrodes6 can vary in the power configuration and layout. For example, the end of eachflex circuit89 can terminate with onelarge electrode6 instead of twosmaller electrodes6.
• Folding of thedeployable membrane34 can occur distal to the end of thecatheter57. A shaft46 (seeFIGS. 20A-20C) can be withdrawn in a proximal direction to fold themembrane34 distal to the end of theshaft46 andcatheter57. The folds of themembrane34 do not therefore contribute to bulk and overall diameter of thecatheter57. Alternatively, in other embodiments and membrane shapes, theshaft46 can be extended fully distally while elongating the membrane34 (in particular an elastic membrane) to minimize bunching of the membrane material. An outer sheath (not shown) can additionally be used to cover the folded upmembrane34 providing theelectrode assembly105 with a smooth outer surface for better delivery, for example through the vasculature. Thedeployable membrane34,electrodes6 and flexcircuits89 can all fold up such that they fit inside a specified sheath size appropriate for the anatomical site to the treated. This allows for a smaller diameter of catheter shaft and, in turn, a very low profile delivery configuration of the device, which minimizes the trauma and risk of complications.
• As shown inFIGS. 24A-24B, themembrane34 can fold preferentially, for example along, between or across theflex circuits89 andelectrodes6 when deflated or in the unexpanded state. The folding can occur in an organized, controlled, predictable and repetitive manner. Theflex circuit89 can also act to influence folding along a preferential folding line and provide for or aid in better packing of the electrode assembly into a low profile delivery configuration.
Catheter
• As described above, the electrode assemblies described herein can be mounted onto a catheter configured for percutaneous delivery. Control of the movement of catheters in general can be somewhat difficult due to the elongated, tubular structure. To provide sufficient control over the movement, the catheters described herein can be somewhat rigid, but not so rigid as to prevent navigation of the catheter through the body to arrive at a precise location. Further, the catheter should not be so rigid that it could cause damage to portions of the body being treated or through which it is passed. The catheters described herein can be manufactured of a variety of materials known in the art of percutaneous catheters including extruded polyether block amid (PEBAX) or other polymeric materials such as polyurethane, polycarbonate, nylon, FEP, PTFE, LDPE, and HDPE. The catheters described herein can be reinforced as known in the art such as with a braided or coiled layer of stainless steel to increase torsional rigidity. Other reinforcement materials and constructions can be used both metallic and polymer based. The catheters can also be formed to a desired shape, such as a curved tip, for ease of placement into the proper orientation. One typical method of shaping a catheter is through thermal re-forming of an extruded catheter which can be done pre- or post-assembly of the catheter. The catheter needs to be of sufficient length and adequate diameter to reach the target tissue through known access points without causing trauma to the tissue during introduction and tracking through the anatomy.
• The catheters described herein can include alaser cut region3 in a variety of patterns, such as an interlocking zigzag pattern or similar, to optimize flexibility while resisting compression and tension (seeFIG. 25A).FIG. 25B shows a close-up of alaser cut region3 having teeth lined up at every row.FIG. 25C shows a close-up of alaser cut region3 of the catheter having teeth lined up at every other row. This pattern can be more resistant to tension or compression compared to the pattern ofFIG. 25B. This laser cutregion3 can be added to any of the catheters described herein such as the guide catheter or electrode catheter or other catheter to increase the ease of use and improve manipulation of theelectrode assembly105. The laser cutregion3 can be constructed of metallic or polymeric material and an addition to the catheter or part of the catheter structure.
• The catheters described herein can be steerable in multiple directions and can be held at various degrees of bend during the procedure as shown inFIG. 26A-26C. Generally steerable shafts or sheaths allow for motion at the distal end of the catheter itself. External elements distal to the shaft or sheath tip can move indirectly. Furthermore, a steerable shaft located within a steerable sheath can result in a loss of function as the shaft is constrained within the sheath. Embodiments described herein allow for steering of the distal most element of the shaft, for example a membrane attached to the shaft.
• In an embodiment, thesupport arms44 can be used to aid in maneuvering thecatheter shaft57 in a distal and proximal direction. As shown inFIGS. 20A-20C, themembrane34 was coupled to thecatheter shaft57 using one ormore support elements44 extending from the distal end of thecatheter57 to provide better control of positioning and orientation of theelectrode assembly105 against the tissue. Thesupport elements44 can be a shape memory material such as Nitinol and can have radiopaquevisual orientation markers49 in the form of a specific shape or element on thesupport elements44 or the materials may in themselves be radiopaque. These can be used to identify the orientation of the device as will be described in more detail below.
• FIGS. 27A-27C show various embodiments of a steerable ordeflectable catheter57 having amembrane34 mounted on its distal end. The embodiments ofFIGS. 27A-27C are examples and other embodiments are possible.Steering elements56 can be placed on themembrane34 to allow for precise control and placement of themembrane34. Theseelements56 can be attached to themembrane34, directly or indirectly, anywhere distal to the junction of themembrane34 andcatheter shaft57. The use of thesteering elements56 allows for easier use of the device especially in more tortuous anatomies. Theelements56 can be used in a pulling configuration and/or have the ability to push. The ability to steer at themembrane34 eliminates any constriction an outer sheath or a traditional steerable shaft (not shown) may have on the full range of motion. The ability to steer distal to the junction enhances the overall maneuverability of the device.Multiple steering elements56 spaced equally or not can be used to allow for the desired degree of maneuverability.FIGS. 27A and 27B show the use of threesteering elements56. In an embodiment, when one of thesteering elements56 is pulled (FIG. 27B), only themembrane34 is deflected. Thecatheter57 remains unchanged or flexes just slightly.FIG. 27C shows amembrane34 with foursteering elements56 mounted on asteerable catheter57. In this embodiment, when thesteering element56 is pulled, themembrane34 and the distal end of thecatheter57 can both flex. In an alternative embodiment, only themembrane34 can flex.
• The catheter shaft can also include an anchoring system for stability and orientation. For example, suction can be applied through the shaft to stabilize the device over a specific region on the tissue. The catheter shaft can also be used to inflate the expandable membrane structure with a gas or fluid. This will be described in more detail below.
Assessment and Control of Energy Transmission to Tissue
• Excessive energy applied to tissues can cause collateral damage such as charring and clotting. Conversely, the lack of good apposition of electrodes to target tissues can result in sub-optimal transmission of energy particularly in anatomical areas having complex three-dimensional geometries. As such, assessing the progress of energy transmission as well as adjusting and controlling the energy delivered can be used, particularly without the need for removing the device is beneficial. The devices described herein can include other features to assess and control the energy transmission in real-time. For example, the devices described herein can include temperature sensors, mapping electrodes, irrigation mechanisms, visualization systems, radiopaque markers, fiber optics, pressure sensors, heat dissipation pattern recognition software, impedance measurement software, anchoring mechanisms and other control mechanisms as will be described in more detail below. With reference to temperature measurement, theelectrode assembly105 or the distal end of the catheter shaft may incorporate a microwave radiometer which can monitor temperature remote form the sensor within a target tissue. This is in contrast to more traditional temperature sensors such as thermistor or thermocouples which require contact with the tissue of which the temperature is being monitored. Such a sensor is especially useful when the target tissue volume is within a tissue mass and not on the surface to which the ablative elements are in contact. Such a technology is described in US Patent Application Pub. No. 2009/0312754, which is incorporated by reference in its entirety.
• Pressure sensors can be mounted within theelectrode assembly105 or in theirrigation pump1005. Such sensors will allow for control of the pressure internal toinflatable structure34 of theelectrode assembly105. The output of such devices can help the user to understand contact pressure. Additionally, such pressure information can be used to control the conformability of the expandable structure. In particular by maintaining the internal pressure of the expandable structure a level where tension in the walls of the structure are minimal when the structure is not in contact with any tissue structure, the walls and affixed electrode will be more conformable to the target tissue structures on application by the user. Such pressure control will also enhance the swiveling action described with reference to the toroidal structure ofFIG. 18H.
• Pressure sensors can also be used to monitor that electrode irrigation throughirrigation holes7 is maintained and properly functioning when the system is run under flow control. Holes can be sized and distributed such that within a given pressure range the flow rate of irrigation fluid is maintained within predetermined boundaries. Alternatively, two flow sensors and a restrictor may be used as a flow monitor to verify proper system performance. Irrigation flow ranges will depend on the particular device and its intended use. Flow ranges of particular merit are in the range of 0.1 to 0.4 mL/min/mm̂2.
• Cooling procedures, either by direct irrigation at or near the electrodes or circulating cooling fluids through the expandable structure, are especially useful when the target tissue is not at the surface to which the electrodes are in closest proximity, but deeper into the adjoining tissue. Cooling the expandable structure or the irrigation fluid can allow for higher energy delivery while protecting the tissue near or in contact with the expandable structure while still allowing damage to tissue further away from the electrode. One such embodiment which allows for irrigation is shown inFIG. 63A. Themembrane34 is attached to theouter shaft57 at the proximal end and toinner shaft134 at the distal end, theinner shaft134 being of a smaller diameter than the shaft157 allows for passage ofsaline30 in between the two shafts. The ends of the membrane may be thickenedsections35. In this particular embodiment, theflex circuit89 is affixed to theinner catheter134 and the distal branches of theflex circuit87 are affixed to themembrane34. Passage ofsaline30 or other irrigation fluid is allowed as the flex circuit is slotted in the transition region. A close-up of the construction ofFIG. 63A is shown inFIG. 63B. The distal branches of theflex circuit87 are attached to the outside of themembrane34, so the transition from the attachment to theinner shaft134 to attachment to theouter shaft57 occurs at or near the membrane junction. This transition section will also contain the slotted features for saline passage. The membrane at this attachment point is not attached to theinner shaft134 which allows the space necessary forsaline30 to flow through into the membrane and provide a cooling mechanism.
• FIG. 63C shows an alternate embodiment which can be used both for the irrigation and for recirculation of a cooling fluid. This embodiment expands on the previously described embodiment inFIGS. 63A and 63B, by incorporating aninner shaft134 with two lumens, one of which is used as a return for the cooling fluid. The membrane is inflated withsaline30 via theinflation lumen36 and,saline30 exits via the opening into the flow return lumen of theinner shaft134. The other lumen in theinner shaft134 is used asguide wire lumen133.Inner shaft134 and theguidewire lumen133 may be separate entities of a multi-lumen catheter. Irrigation may also be incorporated with a circulating fluid cooling system by additional saline exit holes at the membrane as previously disclosed. Irrigation and recirculation cooling are facilitated by theirrigation pump1005 andirrigation source1003 depicted inFIG. 64. In situations where only irrigation is provided these system components may be replaced with a spring loaded syringe.
• In combination with the cooling procedures just described the configuration of the power source and means of power application to the electrodes and thereby the tissue can play a significant role in protecting the tissue more proximal to the electrodes allowing the generation of ablative energy deeper into the tissue. With reference to RF ablation and cooling by irrigation or recirculation, the two generator (RFG) electrode configurations presented inFIG. 67A-67B are of particular interest. InFIG. 67B is presented a somewhat traditional RFG arrangement. TwoRFGs48 are connected to twoelectrodes6 and when properly energized current2 travels between the electrodes. In this configuration the negative outputs are connected in common across the bank of RFG's powering the electrodes. In such a configuration, pulsing RF will allow tissue closest to the cooling means to dissipate heat energy without heating the cooling means. The heat generated deeper into the tissue during the on time of the pulse is dissipated more slowly as the thermal resistance between it and the cooling means is higher thereby minimizing substantial heating of the tissue surface proximal to the electrodes. InFIG. 67A, an alternate arrangement of RFG electrode interfacing is presented. In this configuration eachRFG48 interfaces across a pair ofelectrodes6. EachRFG48 and its pairedelectrodes6 are completely isolated from one another. Sets of paired electrode are energized simultaneously. In such a configuration the current2 in the area between theelectrodes6 is doubled there by increasing the power by a factor of 4. As illustrated only current at the surface of the tissue is portrayed, but in fact the effect is occurring in 3 dimensions. Combinations of these techniques may be used to more effectively ablate tissues further from the electrodes while providing some protection to the tissue in close proximity.
• It should also be appreciated that a variety of elements are described herein and that they can be used individually or in a variety of combinations. Features described herein in the context with or respect to one device, assembly or system can be implemented separately or in any suitable sub-combination with other devices, assembly or systems.
Sensing Electrodes
• The devices described herein can include one or more electrodes that can be used for a variety of functions, including but not limited to ablation, sensing, stimulating and/or mapping. Mapping electrodes can be used, for example, to sense intrinsic cardiac activity and measure the conduction block during and/or after ablation for the treatment of atrial fibrillation. In an embodiment in which atrial fibrillation is being treated, mapping electrodes can be incorporated to measure EKG during the procedure without the need to introduce a separate device. The variety of electrodes can be deposited using the same or similar techniques and materials as described above.
• In an embodiment, the electrode assembly includes a combination of mapping and ablation electrodes. The mapping electrodes can be interspersed between the ablation electrodes on the electrode assembly. For example, asmall mapping electrode51 can be positioned in the middle of alarger ablation electrode6. Each of theablation6 andmapping electrodes51 can be connected to their ownindividual trace16. The configuration ofmapping electrodes51 can allow for confirmation of conduction block by comparing conductivity before and after ablation. Further, the proper number of thesemapping electrodes51 can help identify the direction of electrical signals to confirm proper conduction block. In an embodiment, at least 10 small electrodes can be dedicated for mapping. In another embodiment, at least 20 small electrodes can be dedicated for mapping. The mapping electrodes can be evenly spaced and arranged in a pattern similar to the ablation electrodes. In addition, the larger ablation electrodes can also provide mapping capabilities but the smaller mapping electrodes provide a more accurate measurement.
• One ormore mapping electrodes51 can be incorporated with theflex circuit89. As shown inFIG. 7A-7E,mapping electrodes51 can be connected to theflex circuit89 via aconductive pad59. Themapping electrode51 can be located on top of or in between twoelectrodes6, such as ablation electrodes, and remain electrically isolated from theelectrodes6. Each of theablation electrode6 and themapping electrode51 can have their individual conductive traces16. Themapping electrode51 can be about the same size as itsconductive pad59 or can be laid over both theconductive pad59 and thetemperature sensor90, if in proximity. Thetemperature sensor90 and correspondingconductive traces16 can be insulated from the mapping electrode by a non-conductive adhesive for example. As shown inFIG. 7E, themapping electrode51 can be positioned more distally on the flex circuit such that less advancement of a catheter is needed for measurement of an electrical signal when measuring inside the pulmonary vein.
• In an embodiment, amapping electrode51 can be positioned on anexpandable membrane34 havingablation electrodes6.FIGS. 28A-28D show embodiments of an expandable, closed membrane structure engaged in thepulmonary vein80. Themembrane34 can includemultiple electrodes6 deposited thereon. Someelectrodes6 can be deposited on a region of the membrane that has a larger diameter. This region of themembrane34 can be more proximal and, for example, contact the antrum of thepulmonary vein80 to create an energy transmission line on thetissue83. Thesmaller mapping electrodes51 can be deposited near a distal region of themembrane34 for mapping electrical activity originating from the veins. Aguidewire40 is shown and can be used for better positioning of themembrane34.FIG. 28B shows an alternate embodiment in which the guidewire lumen is retracted proximally to decrease the size of the mapping section of themembrane34. This can allow for mapping in smaller anatomical regions.
• In another embodiment, the mapping electrodes can be positioned on anexpandable membrane34 having themapping electrodes51 between theablation electrodes6.FIGS. 28C-28D illustrate anelectrode assembly105 which is partially deflated prior to introduction into thepulmonary vein80. Once inside thepulmonary vein80, theelectrode assembly105 can be re-inflated if necessary to ensure good tissue contact of themapping electrodes51. Aguidewire40 is shown and can be used for better positioning of themembrane34.FIGS. 28E-F illustrate an embodiment where ablation electrodes and mapping elements are helically arrayed around the cylindrical electrode structure ofFIG. 18P. In this embodiment the mapping electrodes are arranged in a helical pattern between two sets to ablation electrodes.
• In an embodiment, folding of theelectrode assembly105 and deflation of theexpandable membrane34 exposes the mapping electrodes51 (seeFIGS. 24A-24B). Theelectrode assembly105 can fold preferentially when theexpandable membrane34 is deflated. The deflated assembly with exposedmapping electrodes51 can be inserted into the pulmonary veins and used to map the electrical signals. Once mapping is performed, themembrane34 of theelectrode assembly105 can be re-expanded or re-inflated allowing for theablation electrodes6 to be used at their full size. During deflation, themembrane34 can begin to fold at areas of themembrane34 not covered by the flex circuit or areas adjacent to theflex circuits89. Theelectrodes6 can also fold in this process as theelectrodes6 are flexible and carry similar mechanical properties as thebare membrane34.FIG. 24A shows an expandedmembrane34 ready for ablation. Theflex circuits89 are shown to contain onemapping electrode51 each, although there can be one ormore mapping electrodes51 perflex circuit89.FIG. 24B shows the membrane beginning to fold, initially at the sections not covered by a flex circuit such that theflex circuits89 remain exposed. It is important to note that the membrane may not be fully deflated for this procedure. Also, re-inflation of the membrane once inside the pulmonary vein is possible to ensure themapping electrodes51 are in full contact with the tissue.
• Themapping electrodes51 can also be positioned on a device separate from the ablation assembly such as a second expandable structure as shown inFIGS. 29A-29C.FIG. 29A shows an example of a two balloon integrated ablation and mapping system having a separate balloon formapping69. Thissecond balloon69 can have a separate inflation hole68. The guidewire lumen can be located on one side of theballoon69 to allow for better control of theballoon69 position. Thesecond balloon69 can also be used to anchor the electrode assembly during use.FIGS. 29B and 29C show aproximal ablation balloon34 coupled to adistal mapping balloon69. The two balloons can be part of a single catheter or can be separate devices. Each of the balloons can include electrodes for ablation and/or mapping, or electrodes to perform other functions such as sensing or stimulating. Aguidewire40 can be used for example to center themapping balloon69 for better positioning of themapping electrodes51.
• In an embodiment, the mapping electrode structure can be a tubular structure such as amapping catheter45 as shown inFIG. 30. Thecatheter45 can serve as a guidewire for the ablation assembly as well as provide mapping information. The distal end of themapping catheter45 can wrap around an inside surface of thepulmonary vein80 and measure electrical signals.FIGS. 31A-31B also show a linearmapping electrode catheter45. Themapping catheter45 can be used also as a guidewire and can be the same diameter and length of a standard guidewire. In an embodiment, themapping catheter45 can be between about 0.035″ and 0.038″. In an embodiment, the diameter of themapping catheter45 does not exceed 0.035″ and can be interchanged with a conventional 0.035″ guidewire. Themapping catheter45 can be manufactured of a flexible outer shell with an inner diameter that allows for a core element (not shown) to be inserted which will determine the shape, size, and stiffness of the catheter. As shown inFIG. 31A, the core can create a loop shape on thecatheter45 where themapping electrodes51 can be located. The loop as shown inFIG. 31A can be off-center or centered. The loop shape of thecatheter45 can be adjustable in size and can conform to the pulmonary vein for mapping. A section distal to theelectrodes51 can be atraumatic and behave like a standard guidewire tip and terminate as a standard guidewire, for example a J-tip as shown. The distal end can be closed such that it does not allow the core to protrude beyond the tip. A steerable element (not shown) can be included to manipulate the distal end of the catheter.
• Themapping electrodes51 can be deposited using the same or similar techniques and materials as the electrodes described above. Theelectrodes51 can be formed with electro-conductive ink which can be painted, printed, sprayed, deposited or otherwise transferred onto the catheter as described above with respect to the ablation electrodes. The ink can include radiopaque additives for visualization under fluoroscopy or a radiopaque ink pattern can be included adjacent to or on top or below the electrodes. A thin, conductive film and/or conductive adhesive gel can be cut into strips and wrapped around the catheter to serve as themapping electrodes51. Use of a conductive adhesive film or gel can also serve to secure the end of the flex circuit. The conductive adhesive can be created by mixing conductive particles, such as silver flakes, into a flexible adhesive.
• During mapping, thecatheter45 can be extended distal to the expandedmembrane34 as shown inFIG. 31A. If not in use, the shaped section of themapping catheter45 can be retracted into or proximal to the expandedmembrane34 as shown inFIG. 31B. A mapping wire can be the same diameter of a guidewire. In an embodiment, the proximal handle end of the mapping wire can be detachable to allow for other devices to be inserted over the mapping wire.
• In another embodiment, the mapping electrode structure can include a scaffold or braided, self-expandingstructure98 that can be pushed distal to an expandedmembrane34 andelectrode assembly105 as shown inFIG. 32A-32B. Themapping structure98 can be covered by amembrane54 and can include one ormore mapping electrodes51. In its retracted configuration as shown inFIG. 32A, themapping structure98 can be elongated, narrow and positioned within the guidewire lumen. Themapping structure98 can be attached to a movingelement55. The lumen can remain open for aguidewire40 to travel through. When mapping is performed, themapping structure98 can be pushed distal to the expandedmembrane34 and can self-expand (seeFIG. 32B). Themapping structure98 can have a tapered or funnel-shaped structure near where it attaches to the movingelement55. The funnel shape can allow for easier retraction of themapping structure98.Mapping electrodes51 can be mounted on the expanding portion of themapping structure98 in a variety of patterns, such as a single or multiple rows.
• In another embodiment, the mapping electrode structure includes a mapping wire (seeFIGS. 33A-33B). Apre-shaped core74 can be used with a coil75 wound tightly around it. The flex circuitmain lead17 of theflex circuit89 can be wrapped and bonded over the surface of the coil75. Multiple flex circuit main leads17 can be used in theflex circuit89 and theconductive layer96 can be located at specific intervals. Themapping electrodes51 can be formed circumferentially around the wire using conductive ink at each of theconductive sections96 as described above.FIGS. 33C and 33D illustrate another embodiment of a mapping wire. In this embodiment, apre-shaped core74 can be used and aflex circuit89 wrapped over it. An insulated coil75 of a non-conductive material can be wound around the inner assembly, tightly at the proximal end and varying at the distal end. The sections that are not tightly wound can correspond to theconductive sections96 of thelead17. Aconductive filler material26, such as an adhesive, epoxy, or the like, can be used to fill the gaps between the flex circuitmain lead17 up to the surface of the coil75. Themapping electrodes51 can be formed circumferentially around the coil using conductive ink at each of theconductive sections96.
• FIGS. 34A-34F show various embodiments of aflex circuit89 that can be used for the mapping wire. Conductive traces16 on aflex circuit89 can end in an L-shape. The proximal end of thelead17 can be routed to the handle (not shown). The short L-arm of thetrace16 can be exposed and provide theconductive pad59 for the electrodes. The flex circuit can be wrapped over the inner assembly of the mapping wire so that the conductive section forms a loop around the core and connects to itself as shown inFIG. 34B. The loops then can become theelectrodes51 themselves or theelectrodes51 are formed using the same or similar conductive material as described above.FIGS. 34C and 34D show two embodiments of the termination of the conductive section. In a first embodiment, the tabs at the end can be bonded or secured in place via adhesive or an outer bonding layer without disturbing the conductive pad. In another embodiment a self-locking mechanism can be used.FIG. 34E shows straight traces16 on aflex circuit89 withconductive tips59 ending at different locations relative to the edge of theflex circuit89. Theflex circuit89 can be wrapped over the inner assembly of the mapping wire with each conductive section ending at specific locations on the length of the catheter. Alternatively, as shown inFIG. 34F, the traces can be wound around the inner assembly similar to a coil. At each conductive section,electrodes51 can be laid circumferentially around the inner assembly.
• The devices and electrode assemblies described herein can also include one or more pairs of pacing and capture electrodes91 to verify that the lesion created was effective in obtaining action potential block through the ablation line. As shown inFIG. 12, thelarge electrodes6 can be used to create the ablation lesion lines for the treatment of atrial fibrillation, for example, as current92 is passed between theadjacent electrodes6. Current92 can also skip over one electrode to reach the next to create the desired line as shown inFIG. 12. The pattern ofelectrodes6 can be designed to create segments of interconnecting lines, for example to isolate the pulmonary veins and other areas in the heart. Multiple applications of energy can be applied by theelectrodes6 to adjacent or overlapping tissue regions. Pacing and capture electrodes91 can be used, for example during creation of a lesion with the RF power on or in between delivery of energy. In an embodiment, two or more sets of pacing and capture electrodes91 can be included. One set of electrodes91 can deliver the pacing action potential and the other set of electrodes91 can be located behind the lesion line to be created to sense or “capture” the action potential delivered. When the ablation line is complete and there are no open electrical gaps in the tissue, a single pair of these pacing and capture electrodes91 (one pacing, one capturing) may be used to verify the action potential block. Whereas during creation of the first portion of the lesion line at the start of ablation energy application the action potential can travel around the lesion line to reach the capturing electrode. In this scenario, a larger number of (e.g. more than two) pacing and capture electrodes91 can be used to identify the direction from which the action potential came. The pacing and capture electrodes91 can be used to identify whether the action potential came through the lesion line or around it thus identifying where additional energy transmission may be necessary. The multiple pacing and capture electrodes91 can detect direction of the action potential by identifying which electrode detected the action potential first, second, third, fourth and so on. With this feature, the user can verify signal blockage after each segment of the lesion instead of waiting until the overall lesion is created.
Control of Energy Transmission
• The electrode assemblies described herein are conformable such that they provide good contact with the target tissues, especially tissues having complex three-dimensional geometries. Mechanisms can be incorporated into the devices described herein that improve contact of the electrode assembly with the target tissues. In an embodiment a support structure such as a balloon can be used to press the electrode assembly against the target tissue (seeFIG. 35). In this embodiment, a distal and relatively smallexpandable electrode structure34 that includeselectrodes6 on its outer surface is positioned against the target tissue. A largerproximal support structure39 can assist in positioning theelectrode structure34 by pushing thesmaller electrode structure34 against the tissue. A guidewire or guiding rod85 is shown that can also be used to assist in positioning.
• Heat and current can dissipate quickly away from a region to be treated if for example a heat sink is present such as a near-by pool of blood such as a large artery, vein, or the coronary sinus. This results in sections of the tissue not getting sufficient energy transmission and the failure of a conduction block. Because of the poor heat transfer of energy through gas compared to a liquid such as blood, a fluid-tight structure filled with a blood-safe gas, such as carbon dioxide or helium, can be provided near the location of energy delivery. As shown inFIGS. 36A-36B, a gas inflated balloon94 can be placed in the coronary sinus for example and used such that current2 can pass from theelectrodes6 on theelectrode structure43 to areference electrode6 on the gas-inflated balloon94. The tissue between can then be appropriately ablated. The gas-filled structure can also be used for temperature measurement and feedback.
• As described above, theflex circuit89 can havetemperature sensors90 mounted onconductive traces16 near, on or betweenelectrodes6 in contact with the tissues. Thetemperature sensors90 provide feed back to the user as to the temperature of the target and surrounding tissues such that the device and/or the user can modulate energy supply and charring or excessive coagulation can be avoided. Controlling the temperature, for example using irrigation at or near the tissue treatment site, is another way in which charring can be prevented. As shown inFIGS. 37A-37C, irrigation holes7 can be positioned near one or more of theelectrodes6 to deliver a cooling fluid to the region and maintain consistent, predictable pattern of energy transmission. The fluid can include a non-conductive or conductive irrigation medium. The figures show irrigation holes7 for threeelectrodes6, but it should be appreciated that more or less than threeelectrodes6 can have irrigation holes. In an embodiment, allelectrodes6 have one or more irrigation holes7. The irrigation holes7 can be contacting or adjacent to an electrode, for example surrounding the border of theelectrode6. In another embodiment such as shown inFIG. 37B, the irrigation holes7 can be placed directly on the surface of theelectrode6 near the edge of theelectrode6. It should be appreciated that the irrigation hole may be placed anywhere on theelectrode6.FIG. 37C shows yet another embodiment withirrigation holes7 located in between twoelectrodes6 soadjacent electrodes6 share a set of irrigation holes7. It should be appreciated that the configuration ofirrigation holes7 toelectrodes6 can vary and that the configurations provided in the figures are for example only.FIG. 37D shows asingle irrigation hole7 located at the center of each electrode (only six holes are shown). In one embodiment, theseirrigation holes7 can match with holes placed on the flex circuit conductive pad59 (seeFIG. 3B). In one embodiment the flow rate of the irrigation fluid can vary and be controlled to a desired level. The irrigation flow rate can be set to a minimum level to maintain pressure within a closed membrane, such as a balloon for example, while positioning or orienting the catheter. Alternatively, cooling fluid can be circulated within a closed membrane without the use of irrigation holes.
• When irrigation fluid delivery is the means by which the balloon inflation is maintained, the size and number of holes becomes important. The fluid resistance of the sum of the holes should be such that for the required flow of irrigation fluid the pressure drop across the sum of the holes is that required to maintain the balloon inflation. As the pressure drop across a hole for a given flow rate varies as a 4th order function of the diameter, a preferred embodiment has many smaller holes such that more averaging can occur. In addition to averaging, when lower exit fluid velocities are desired, many smaller holes provides an advantage over fewer larger holes.
• InFIGS. 37E-37F are illustratedirrigation holes7 incorporated as part of theflex circuit89. When theirrigation hole7 is configured in this fashion the increased stiffness associated with theflex circuit substrate52 singly or in combination with theconductive layer96 and other layers may be used to advantage as a means to provide extra strength to the irrigation hole and thereby prevent tearing of themembrane34 at the irrigation hole during manufacture or use. The flex circuit in proximity to the hole can be affixed to the expandedmembrane34 via an adhesive95 or other bonding process during manufacture. Thehole7 inflex circuit89 can additionally be used as a template for hole placement by drilling, puncture, or other suitable process during manufacture. In this fashion placement relative to the electrodes and the size of hole may be more closely controlled, which are both factors important in the process of irrigation. Both hole placement relative to the electrode and the cross section and cross sectional area of thehole7 will be important in controlling the volume flow of irrigation fluid in proximity to theelectrode6. The irrigation hole as illustrated inFIGS. 37E-37F has been shown such that the irrigation hole passes through all theelectrode96,substrate52, and adhesive95, layers of theelectrode assembly structure105 ofFIG. 1A. Theirrigation hole7 as described may, however, be used in anyelectrode structure105 herein described incorporating aflex circuit89. Theirrigation hole7 may also be configured such that it passes through any or none of the layers associated with the disclosed structures ofelectrode structure105 so long as theirrigation hole7 passes at least one of the layers associated with theflex circuit89.
• The devices and electrode assemblies described herein can incorporate a variety of mechanisms that allow the user to assess the extent, orientation and quality of treatment line as well as the orientation of the electrode assembly itself in real-time during a procedure without the need to remove the device. For example, energy transmission can be visualized and assessed through the deployable membrane of the device such as, for example, using incorporated fiber optics or a camera on a chip.FIGS. 38A-38G show aballoon34 havingelectrodes6 mounted on its surface as well as afiber optic scope38 to visualize the tissue as it is being ablated. Thescope38 can be positioned on an interior of theexpandable structure34 as shown in the figures or an exterior surface of theexpandable structure34.
• In an embodiment, more than onefiber optic scope38 can be used in the electrode assembly105 (seeFIGS. 38D-38G). Thefiber optic scopes38 can be wrapped helically around aninner shaft12 with aflexible shaft57 or be placed adjacent to theinner shaft12 to achieve a desired field of view (“FOV”). The scope(s)38 can also be fitted with angular viewing optics to achieve a different view. For example,FIG. 38D illustrates thescope38 wrapped around theinner shaft12 to achieve the FOV shown. Thesame scope38 inFIG. 38E goes straight through theshaft12 but to achieve the same FOV, an angular viewing optic can be used. In one embodiment, thefiber optics scope38 can be movable along the axial length within themembrane34. This can aid in the confirmation of good apposition to the tissue when theelectrode assembly105 is already in place.FIG. 38G shows a close-up view of fourscopes38 wrapped helically around an inner shaft. Radiopaque markers can also be used to aid in determining the orientation of the electrode apparatus during use.FIG. 20A shows radiopaquevisual orientation markers49 coupled to thesupport arms44. Theorientation markers49 can have a variety of specific shapes that can be used, for example by a software projection algorithm from the fluoroscope output. Mapping data can be combined with orientation data from themarkers49 to visualize and allow the user to select whichelectrodes6 to activate and use for the desired energy transmission. A user interface can display the orientation of the device, for example on a screen on the RF generator, and this image can also be superimposed on a fluoroscopic view.FIG. 38H illustrates a front view of anelectrode assembly105 incorporating visualization system and the field of view for one of four such optical sub-assemblies incorporated in the optical assembly. Each of the optical sub assemblies incorporates anoptics structure142, which interfaces to anillumination fiber141, a 200micron fiber bundle140, such as the Sumitomo Image Guide IGN-02/03, and anoptics structure142. A quarter section of theelectrode assembly105, with flex circuit89 (not shown) andinner shaft57 for visualization of the fibers, is depicted inFIG. 38I.Illumination fiber141 andimage guide140, in the depicted embodiment, travel within inflation lumen36 (seeFIG. 6C) to handle1006 (not shown) and on to visualization system control1004 (not shown). The sub-assemblies are fitted into the toroidalexpandable membrane34 singly and locked in place around theinner shaft57 at the time of assembly of the visualization system. Other arrangements not depicted route the fiber bundle and illumination fiber through an additional lumen in the inner shaft134 (not shown).
• In any of the embodiments represented inFIGS. 38 A through I, the visualization systems incorporating fiber scopes and fiber optic illumination may be replaced with visualization systems which incorporate either cameras and/or LEDs at the distal end of the ablation system.FIG. 38J depicts a component sub assembly of such a visualization system comprised of two sub assemblies. The two sub assemblies comprisingsub assembly210 are a camera sub assembly and an illumination sub assemble, each fabricated by molding the active components into an optical grade of polymer. The visualization system ofFIG. 38J is configured similarly to the structure described inFIG. 38I, however the optical fibers which comprised the fiber optics scope orimaging bundle140 has been replaced withcamera240, and theillumination fiber141 has been replaced withLED241. The camera is mounted inoptic structure242 and the LED is mounted inoptic structure243. As depicted the three visualization sub assemblies comprise atotal visualization system200. The three sub assemblies comprising the total system provide for a smaller fabrication cross section and ensuing advantages as described elsewhere here in. Such a complete system is depicted inFIG. 38K mounted within a toroidalflexible membrane34 structure for carrying ablation electrodes as described herein. A visualization system alternatively may incorporate more orless subassemblies210. A flex circuit as described herein can be adapted to interface a camera when used.
• The visualization system ofFIGS. 38 J, K, and L are structured such that the FOV for both the camera element and the illumination element are fixed relative to the directions in which they point, which as depicted are at an angle of about 60 degrees relative to the cylindrical or longitudinal axis ofinner shaft134.Camera elements240 andLED elements241 are distributed about 120 degrees apart from adjacent camera elements and LEDs, respectively, around the longitudinal axis. The camera elements and LEDs are offset with respect to each other by about 60 degrees. In this fashion the FOV's for the camera elements and those for the LED elements overlap as depicted inFIG. 38L. Such embodiments have an added advantage in that during delivery they can flex in towards the center of the opposite of what is shown and thereby present a reduced cross sectional profile. Where such a feature is desirable, the camera might be placed proximal to the LED.
• Another alternative visualization system in which the direction in which the FOV's for the camera and illumination elements may be adjusted is depicted inFIGS. 38M through 38Q. In this embodiment theoptics structures242, along with associated camera and LED, are mounted onflex circuit branches87 of aflex circuit89, as depicted inFIG. 38M, where only oneoptics structure242 is shown mounted to one of the three branches for clarity. As the two ends of theflex circuit89 are displaced axially relative to one another, thebranches87 flex, thereby adjusting the direction relative to the cylindrical axis of the shaft (not shown) to which the visualization system is pointed. In an embodiment such as that ofFIG. 62, the distal end of the visualization system is attached to an inner shaft and the proximal end to an outer shaft or the associated hubs of the toroidal balloon. The distal end of the visualization system ofFIGS. 38M and O is that closest to the camera. The flexingbranches87 of theflex circuit89 may be modified to facilitate preferential bending at bend points245. The substrate may be narrowed at these points such that the width is reduced and or the substrate and or electrical traces may be thinned at these points. Alternatively a NiTi element may be incorporated in the flex circuit at these points.
• In one embodiment of theoptics structure242, the structure is cast in an optical grade of polymer. In such an embodiment some or all of the optics associated with camera and illumination source may be features of the optics structure. Such features known to those skilled in the art are not shown here. Theoptics structure242 may additionally incorporate features which allow for better mechanical interfacing withflex circuit branch87. The optics structure may also incorporate optical dams to isolate the source light from entering the camera from within the optics structure. Alternate preferred embodiments may be fabricated by injection molding as used for fabricating optics.
• In the embodiments depicted inFIG. 38 the fluid used to inflate theflexible membrane34 and the flexible membrane itself will be transparent to the illumination and camera optical pass bands. An exemplary inflation fluid is saline with or without a radiopaque contrast media. A few of the many possible materials appropriate for the flexible membrane are PET and Polyurethanes. In some alternatives CO2 may be used to inflate the membrane. This is particularly advantageous when a camera capable of imaging in the IR is used. Such a system would have particular advantage in monitoring electrode and/or tissue temperature during an ablation procedure.
• FIGS. 38 N and O illustrate the visualization system ofFIG. 38M and associated FOV's for thesub assemblies210 in two different states of flexure. InFIG. 38N, the flex elements are flexed at about 60 degrees relative to the shaft longitudinal axis and inFIG. 38O they are not flexed and the FOV's are pointing in a direction substantially normal to the shaft's longitudinal axis. As can be seen inFIGS. 38N and O there are FOV overlapregions252 associated with some range of angles off of the shaft axis and there are some range of angles for which there is no overlap. When working with multiple cameras, these overlap regions have particular value. At a minimum, in regions where such overlaps exist, a contiguous image of the target tissue is available. Additionally the features within the overlap regions may be used as a basis to process the individual images and knit them together into one contiguous image for presentation to the operator. In addition elliptical and cylindrical lenses can be used to enhance overlap of FOVs. Image processing protocols may also be used to remove distortions associated with such lens use and variations in camera angle.
• The adjustable visualization system ofFIGS. 38 M through Q has additional advantage when camera optics are required to be simple such as for cost related or camera volume related concerns. In such situations a camera with a small FOV may be manipulated to view image particular features and/or multiple images which can be knit together to create an image which covers a larger area.
• When capturing multiple images from multiple cameras either sequentially or in parallel, or when capturing multiple images from a single camera sequentially, or both, areas within the images that have sharp features and are imaged in multiple FOV have particular value.FIG. 38P illustrates the visualization system ofFIG. 38M mounted in a fashion similar to that depicted inFIG. 38I where the toroidal balloon comprises threeelectrodes6. The illustration characterizes cameras which are facing five degrees off of the shaft angle. The electrodes are marked to facilitate identification of specific locations within the FOVs. As illustrated they are numbered 1 through 3 and the numbers have been placed both on and off the electrodes. Marking features other than numbers could also be used such as varying the shape of the electrode. Alternatively, any of the means described for the use of radio opaque markers could be used, for instance those illustrated inFIG. 40B. In the illustration ofFIG. 38P the cameras will image the region between the twocircles258 which represent the surface of the toroidal balloon which is in contact with a tissue surface. The full extent of the FOV's250 for the three cameras is shown, but it should be understood that the portions of the FOVs outside the image region will not image tissue. In the illustration ofFIG. 38P the three cameras image thearea253 where all three FOVs intersect. Pairs of cameras FOVs intersect inareas252 andareas251 are imaged by only one camera. In this example the multiple overlap regions and the locational features greatly facilitate the image processing required to knit the images into a contiguous whole. The illustration ofFIG. 38Q characterizes cameras with a tilt of about 45 degrees. In both figures the FOV for the cameras is about 120 degree.
• In alternate embodiments the visualization systems described herein can be comprised of expandable structures with configurations other than toroidal.FIG. 38R illustrates the visualization system ofFIG. 38M with a cylindrical balloon structure. The distal direction is to left on the page, and the remainder of the system has been left out for clarity. As illustrated, the camera has a FOV of substantially 120 degrees and is pointed at substantially 15 degrees off the shaft axis. In such a configuration a contiguous image of the surface to which the balloon structure is adjacent will be recorded by the tree cameras. The height of the contiguous image will be the maximum length of the FOV overlapregion252. In this configuration when the cameras are pointed at less than about 10 degrees the captured image will not be contiguous. In yet another embodiment the fixed visualization system ofFIG. 38J may be used. The design of the visualization system can be adjusted to accommodate the constraints of the particular intended use. More cameras can be used when the constraints require fixed cameras and/or cameras with smaller FOV. Alternatively, larger FOV and/or steerable cameras can be used when constraints require less volume or cost amongst other considerations. In yet another embodiment a single fixed or steerable camera can be used and rotated thereby capturing multiple sequential images which can, by image processing procedures, be knit into a contiguous image.
• Two additional exemplary features of the embodiments of the visualization systems presented herein are the delivery profile of the completed visualization system and fabrication profile of the visualization system or its components. The delivery profile is the profile of the visualization system which is normal to the shaft axis in the delivery configuration. The fabrication profile is the profile of the smallest component which can be assembled within the expandable member. The fixed visualization systems described herein are comprised ofmultiple sub-elements242 and243 which when assembled comprise the completed distal portion of thevisualization system200.FIG. 38K is exemplary of such a design using threesub-assemblies210 to comprise the whole assemble200 that has a fabrication profile equivalent to thefront face subassemblies242 and243. The fabrication profile for the steerable visualization assembly distal section described herein is approximately the front facing surface of theoptical structure242 for the configuration where each of thebranches87 are separate at the beginning of fabrication and can thereby be introduced into the expandable structure separately. In preferred embodiments the optical structure will be designed such that these profiles are minimized. Following introduction the distal ends are then fixed together. The delivery configuration for the steerable visualization system can in some embodiments be made smaller by allowing the individual branches to compress into the center of the delivery lumen. In some embodiments the delivery profile is smaller than the outer shaft.
• In yet other embodiments the distal end of the visualization system ofFIG. 38M can be left free floating such that on delivery the device can be compressed but on deployment it can spring into a delivery configuration.
• Thermochromic inks can be used to create locational markings as is indicated by the ring inFIG.38P electrode number3. Alternatively the entire back surface of the electrode could be covered with a thermochromic ink, in which case temperature uniformity of the electrode can be evaluated.Electrode2 in the figure is represented as a group of parallel lines of conductor separated by spaces and ringed by a common conductor. Such an electrode facilitates viewing the tissue behind the electrode during the ablation process.
• FIGS. 3B,39A-39E, and40A-40B show various embodiments of radiopaque patterns that can be used with anexpandable membrane structure34 for the visualization and orientation of the placement of theelectrodes6 onto the tissue as well as the overall shape of theexpandable membrane structure34. In an embodiment, theradiopaque markers58 can be thin lines or “spines” along the longitudinal axis either between theelectrodes6 as shown inFIG. 39A or directly across the center of the electrodes as shown inFIG. 39B or39C. These spines ofradiopaque markers58 provide an indication of distance betweenelectrodes6 and overall shape of theballoon34 against the tissue. In another embodiment,radiopaque markers58 can be incorporated into the flex circuits that are used to connect eachelectrode6. Layers of denser, radiopaque material such as gold can be added to the conductive pads of theflex circuit89 for visualization. The denser material can also be placed at the distal branch of the flex circuit to create the thin spines. In this embodiment a thin layer of additional material can be used such that the surface or thickness of the electrodes is not altered and an overall low profile of the device maintained.
• In another embodiment theradiopaque markers58 can form lines angled across theelectrodes6 giving the user a sense of whether theelectrode6 is, for example on the anterior or posterior side (seeFIG. 39B). In another embodiment, theradiopaque markers58 can be in the shape of an “X” across theelectrode6 allowing for the center and edges of theelectrodes6 to be pinpointed (seeFIG. 39C). An outline of theelectrode6 can also be traced with radiopaque materials. In other embodiments, theradiopaque markers58 can include dots around or directly on top of the edges of theelectrodes6 such that they outline the shape of each electrode (seeFIGS. 39D and 39E), or they may be centered within the electrode (not shown) as dots or other shapes. Alternatively an electrode material which is both radiopaque and conductive may be used to facilitate these embodiments. In such cases the thickness of the electrode may be varied to adjust the radiopacity. In such an embodiment where it is desired to enhance the radiopacity of the center of the electrode, the full electrode is masked then printed then re-masked to define the thickened area and printed again. This or alternate electrode fabricating techniques can be used in any of the cases where the patterns previously described are applied to the electrodes. Other configurations, shapes, sizes of the radiopaque markers are possible.
• The radiopaque markers can be placed on an electrode assembly at circumferentially asymmetrical intervals along themembrane34. If the deployable membrane of the electrode assembly has an expandable structure such as a balloon, the radiopaque markers can be placed at adjacent quadrants of the balloon or between specified electrodes that are not evenly spaced apart. The markers can be the same or have varying shapes and sizes. Alternatively, the markers can create a distinguishing pattern over the surface of the membrane. In an example, a first quadrant marker can be one dot, a second quadrant marker can have two dots, and a third quadrant marker can have three dots and so on. The markers can include matching markers mounted on the shaft at the same spacing.
• As shown inFIGS. 40A-40C, a radiopaque marker system can be incorporated on themembrane34 of an electrode assembly. In an embodiment, twodissimilar markers58 can be placed at just over 90 degrees apart (quadrants1 and2) and three electrode widths apart. Matchingmarkers58 to those on themembrane34 can be located on the distal end of theshaft57. Under fluoroscopy, the user can determine the orientation of theelectrode structure105 based on the location of themarkers58. The use ofdissimilar markers58 as shown, or varying numbers of dots on each consecutive quadrant as described above, allows a user to determine the orientation of themembrane34 and determine the target energy transmission location. Such patterns may in addition be facilitated by using the techniques described with reference toFIGS. 39D and 39E, where the patterns are created on the electrodes and not all electrodes receive the same treatment. Where rotational orientation is sought, radiopaque markers may alternatively be added to structures other than those located on themembrane34. Such an embodiment is illustrated inFIGS. 40D-40E.FIG. 40D illustrates aradiopaque ring58 affixed on the OD ofshaft57.FIG. 40E illustrates the ring in an unwrapped configuration where the one of a number of possible set features are more easily seen. The transparent portion of the projection passing across the longitudinal axis of the ring created by the triangle and square cut outs has an image which continuously and uniquely varies through 360 degrees of rotation. The ring can be configured to be located in alternate locations such as on the ID ofouter shaft57 or other cylindrical structures within, or on the of thickenedmembrane section35 ofmembrane34, amongst others.
• FIG. 3B illustrates the integration of aradiopaque marker system58 directly onto theflex circuit89. A set ofmarkers58 is shown on twoseparate branches87 of theflex circuit89, for example 1 line and 2 dots. In the embodiment ofFIG. 3D a number of the flex arms of the flex circuit can be modified to enhance the radiopacity by incorporating a unique layer of appropriately radiopaque material, or modifying a conductive layer material, or conductive layer thickness, or both. In such an embodiment the arm incorporatingelectrode pad59c, and the forth, and seventh arms, counting from left to right, incorporate a radiopaque layer which extends from theproximal tab116 to thedistal tab116 for the first arm, ⅔ that distance for fourth arm and ⅓ that distance for seventh arm. Such a unique layer may additionally be created by adhering a foil of a radiopaque material such as silver, tungsten, tantalum, platinum, or gold to the branches of the completed flex circuit or be adhered to theflexible membrane34 independent of the flexible circuit.
• The spacing, number, shape and size of themarkers58 can play an important role in defining the geometry and orientation of the device as well as ease of use of the marker. Thebranches87 of theflex circuit89 can be located at unique latitudes on themembrane34, in particular an embodiment of amembrane34 similar to those ofFIGS. 18A-18M. Themarker system58 can then lie at unique positions on themembrane34. If the markers are spaced out in adjacent quadrants, for example, and are of different shape and/or number, the user can readily recognize a particular marker as quadrant I. Additionally, thetemperature sensors90 and electrodes themselves can serve as radiopaque markers which provide an indication of overall shape of theexpandable membrane34. In some embodiments thermistors of different sizes may be used and distributed in such a way that sections of the electrode assembly between the thermistors are identifiable.
• Other mechanisms can be included in the devices or electrode assemblies described herein that allow a user to assess orientation and quality of energy transmission without the removal or repositioning of the device. For example, sensors located at or near the electrodes can be incorporated to detect tissue contact with the electrodes or the amount of pressure exerted on the tissue during a procedure. Because the amount of contact and pressure can have a dramatic influence on the depth and quality of the lesion being created, it can be important to assess in real-time the extent of contact made with the tissue and the degree of pressure being exerted. The depth of energy penetration and the ability to detect tissue contact with the electrodes during transmission allows a user to avoid thrombus formation and inadvertent charring of the tissue.
• Tissue contact can be measured using a variety of techniques. In an embodiment, software can be programmed such that no significant hardware need be implemented. For example, the measurement of electrocardiograms through the electrodes on the membrane. Signals obtained by the electrocardiogram allow a user to determine whether the electrode is in contact or not. Algorithms can be employed to determine partial contact as well.
• Another method to determine tissue contact with the electrode is to incorporate heat dissipation pattern recognition into the software. A short burst of RF heating can be applied to the electrodes and based on the behavior of heat dissipation the software can recognize whether the electrode is in contact with tissue or is in contact with only blood, for example. A faster dissipation of the heat applied would indicate contact with flowing blood instead of tissue, which would retain the heat longer.
• Yet another method to detect tissue contact with the electrode is through impedance measurements. Contact with tissue can show a change in impedance as compared to blood. The amount of contact force may also be assessed through impedance measurements. This allows for proper determination of not only electrode-tissue contact but amount of force in which they are in contact, which could more accurately predict the depth of the energy transmission to be performed. A number of variables (frequency and amplitude) can be adjusted to achieve the desirable threshold and accuracy to determine the difference between tissue and flowing blood.
• FIGS. 41A-41B illustrate another sensing mechanism using impedance measurements. Theflex circuit89 can contain twoconductive traces16 having non-insulatedconductive pads59 near their distal end and located near or adjacent to the electrodes (not shown), which are in proximity to one another. Impedance can be measured between the twoconductive pads59. In an example, when bothconductive pads59 are in contact with tissue, the impedance measurement will be generally high. When only oneconductive pad59 is in contact with tissue or both ends are not in contact, the impedance measurement will be generally lower.FIG. 41B shows a similar method that allows for largerconductive pads59. This may allow for partial tissue detection based on a larger range of impedance measurements.
• Pressure sensors are known in the art and can be incorporated into the flex circuit. An example is a piezoresistive pressure sensor which can be covered with gel, silicon or another material. Examples of these sensors include GE NPD-240, GE NovaSensor P1602 and Silicon Microstructures SM5102, EPCOS ASB1200V and T5300, and Intersema MS7212. The sensor can be placed on the flex circuits near or at the electrodes.
• Micro-switches can be located at each electrode, for example with additional hardware and/or software integration.FIGS. 41C and 41D illustrate an example of anelectrode6 broken down into 3 separateconductive patches6a,6b, and6c. Eachconductive patch6a,6b, and6ccan have a corresponding micro-switch that is physically activated when tissue is in contact with the electrode. The switch and conductive patch are connected when in contact with the tissue. Once all threepatches6a,6b, and6care connected theelectrode6 can be activated. Theflex circuit89 can be arranged differently between the two figures which may define the overall flexibility and foldability of the assembly.
• In another embodiment shown inFIG. 42, anelectrode catheter71 can incorporate radiopaque, longitudinal “arms”60 that protrude out when the appropriate amount of pressure is being applied by theelectrode catheter71 against thetissue83. If there is no pressure exerted against thetissue83 or not enough pressure being exerted, theelectrode catheter71 has a slender profile with no protrusion of the arms. If too much pressure is being exerted, thearms60 splay such that they can point backward. A specific shape of the arms can be an indicator of proper contact pressure.FIG. 43 shows anelectrode catheter71 that includes anexpandable element62 such as a balloon that can be controlled by avalve61 or other fluid-control mechanism. When the appropriate amount of pressure is being exerted by theelectrode catheter71 on thetissue83, thevalve61 allows theexpandable element62 to be inflated via aninflation lumen36. Electrodes (not shown) can be placed on the distal tip of theelectrode catheter71 for activation when theexpandable element62 reaches the proper size. Theexpandable element62 can be inflated with a radiopaque dye or radiopaque dye can be injected into the bloodstream for visualization.
Electrode Assembly Anchors
• The devices described herein can incorporate various structural elements that provide further assistance in the manipulation and repositioning of the electrode assembly without the need for removing the device and reorienting the device. For example, the electrode apparatus can be independently translatable over an anchor catheter or guide element that is fixed in place at or near the target tissue. The anchor can provide a stable reference point and act as an efficient, quick and controlled repositioning device that the electrode assembly can slidably or rotatably move over, for example to contact the ablation pattern region just created. This allows a user to perform additional energy transmissions, for example in areas that did not result in full trans-mural ablation. Or a user can map and verify the effectiveness of the therapy, for example in areas of the tissue that are thicker or require a higher dosage of energy or several passes of energy transmission.
• The configuration of the anchor device can vary including, but not limited to, a suction catheter, an expandable member such as a balloon or basket, or suction pods that incorporate electrodes and suction mechanisms simultaneously. In an embodiment where cells outside the pulmonary vein are to be treated, for example in atrial fibrillation, an expandable element can be inserted within the pulmonary vein.
• FIGS. 44A-44F show an embodiment of amembrane34 that includes an anchoringbasket50. Themembrane34 is shown as having a balloon structure, but themembrane34 can have another shape and configuration as described above such as a single catheter that extends to an anchoringbasket50.FIG. 44A shows a guide47 (catheter or wire) that can be anchored at the distal end by deploying the anchoringbasket50. Theguide47 can be deployed along the desiredline81. Once theguide47 is in place and optionally a visualization balloon and scope assembly (not shown) advanced over the guide to confirm correct placement and tissue contact, themembrane34 can be retracted (or advanced) while activating electrodes to achieve the desired linear lesion81 (FIG. 44B). After the first linear lesion is made81, theguide47 can be rotated around theanchor50 and re-oriented to create a secondary lesion (FIGS. 44C-44D). Alternatively, a fully or partiallycircumferential lesion81 can be created around the antrum of the pulmonary vein or in combination with the linear lesions described above (FIG. 44E). This can be done by maintaining themembrane34 position relative to theguide47, and rotating themembrane34 around the axis of the anchor. Once the desired lesion set is completed, conduction can be tested for example by monitoring electrical potentials viamapping electrodes51 located onanchor50 deployed within the pulmonary vein (FIG. 44F) as discussed above.
• As shown inFIGS. 45A and 45B, the anchor can also have an expandable structure such as a balloon. Theanchor42 can have a variety of shapes. In this embodiment, theanchor42 can be deployed, for example in thepulmonary vein80 for anchoring and positioning of anelement43. Aguidewire40 can be introduced in thepulmonary vein80 to assist in the location of theanchor42. Theelectrode element43 is shown havingelectrodes6 on its outer surface and afiber optic scope38 that can be rotated for visualization around the circumference of theelectrode element43.
• Controlled repositioning mechanisms using suction can also be used such that some portion of the anchor is in contact with the tissue while another portion is being repositioned. In an embodiment, suction tip catheters can be used to anchor the electrode assembly. The suction tip can be deployed within the pulmonary vein. A suction tip1 can also be used for controlled repositioning of the electrode element. For example, one or more suction regions can be alternately turned on or off to allow a user to guide and move the device, such as an electrode catheter as shown inFIGS. 48A-48B,49A-49D,50,51A-51C, and52A-52D. Suction can be incorporated with an optional inflatable element to improve energy transmission achieved in addition to anchoring such as shown inFIGS. 44A-44F,47,53A-53E,54A-54D and55A-55C.
• An anchoring catheter15 can have a suction tip18 to anchor on the myocardium wall of thepulmonary vein80 to be used in conjunction with a separate electrode sheath76 (seeFIG. 14A-14B). Alternatively, anelectrode sheath76 can be a single catheter that extends to an anchoring basketdistal end50 or terminates in a suction tip18.FIGS. 46A-46B and47, show close-up views of the electrode element having anaspiration lumen4 and a distal region that has an elliptical, rounded or funnel-shaped suctioning tip1. The suction tip1 allows the electrode element to locate and anchor onto an area of themyocardium83 as well as transmit energy in the sameregion using electrodes6. Thetissue83 can be pulled inside the suction tip1 for anchoring and energy transmission. As shown inFIG. 46A, theelectrodes6 can be used in a bipolar configuration allowing the current2 to move from one side of the suction tip1 to the other. Current2 can pass through thetissue83 in a pattern similar tolines2. Alternatively, theelectrodes6 of the electrode element can be used in a monopolar RF energy delivery. Theelectrodes6 can be on the inside surface of the suction tip1 to contact thetissue83 directly or through a fluid layer such as saline. Irrigation holes7 and irrigation lumens8 can be included to reduce the chance of clotting and charring at the electrode site as well as prevent excessive heat build-up. The irrigation holes7 can be placed on the inside and or outside of the suction tip1. As shown inFIG. 47, thecatheter71 can be a catheter having a flexible and torque-able shaft that can be laser cut in a puzzle likepattern3 out of metal or hard polymer. The mainflex circuit lead17 can connect theelectrode6 to the proximal end.
• FIG. 48A shows asteerable sheath9 and a twoarm catheter63 extending from the distal end of thesheath9. The twoarm catheter63 can include two suction tips1 each of which can have electrodes to allow RF energy transmission between the two suction tips1 of thecatheter63. The two suction tips1 can have a funnel shape each disposed with anelectrode6. The suction tips1 allow the electrode to be anchored independently. One suction tip1 of the catheter can anchor onto the tissue, for example by activating the suction, and the other suction tip1 arm moved to the next target tissue region. Movement can occur by moving the suction tip1 guided for example by the pre-determined spacing between the tips1 and atension wire20 that can be controlled by the user (seeFIG. 48B). Thetension wire20 can be pulled to bring the two tips1 towards one another. Release or relaxation of thetension wire20 can allow for the two suction tips1 to spread apart such as due to a spring force in the material of the tips1 and/orcatheter63.
• Once thecatheter63 is positioned ablation can be initiated. The suction tips1 can include one or more electrodes and one or more temperature sensors. The two suction tips1 can be spread apart and suction turned on through both tips1 before energy is applied. Alternatively, the suction can be turned on for a first tip1 and then turned on for the second tip1 before energy is applied. To continue the energy pattern one of the suction tips is turned off and is positioned in another location, for example by rotation or changing the distance between the tips using thetension wire20. To achieve the desired position, the user can alternately turn on and off either of the tips1 and orient thecatheter63 as desired. When creating a particular pattern, the use can keep suction active on one of the suction tips1 and inactive on the tip or tips being moved. The main body of thesheath9 or thecatheter63 can have great flexibility and torque-ability. Thesheath9 or thecatheter63 can include alaser cut pattern3 or have a braided shaft that allows for the catheter to maintain one-to-one torque control, such as after taking out the slack, while providing flexibility/bendability and enhance the ease of positioning of the electrodes.
• In another embodiment, the catheter can include suction pods and two control arms.FIGS. 49A-49D show a schematic representation of the suction catheter having twoproximal control arms21,22. Thecontrol arms21,22 can be positioned next to each other as shown inFIG. 49A. Motion of thecontrol arms21,22 can allow for the catheter to be anchored and positioned as the user desires in a deliberate and repeatable manner. The user can position the catheter in proximity to the region of treatment and turn the suction on through one of the suction holes.FIG. 49A shows both suction holes turned off24 (shown as a white circles). The suction hole can be turned on23 (shown as a darkened circle) to anchor to the tissue. The other suction hole can remain turned off24, for example to allow its associatedcontrol arm22 to be advanced distally (seeFIG. 49B). Once positioned, the suction hole is turned on23 while the other suction hole is turned off24 and the associatedcontrol arm21 moved in similar fashion (seeFIGS. 49C and 49D). Thecontrol arms21,22 can also be moved in a proximal direction using a similar on-off alternating suction mechanism.
• The twocontrol arms21,22 can also be concentric or in apposition to each other (e.g., as opposed to linearly displaced) with the inner tip extended distal to the outer. In the concentric embodiment, the inner tip can move distally while the outer tip is anchored. Then the distal tip suction can be turned on and the outer tip is moved until just proximal to the distal tip. The catheter can rotate around the suction pods (i.e. control arms with suction holes) to achieve lateral motion and/or energy transmission. The suction pods can be made out of conductive material or coated with such to act as theelectrodes6. RF current can be passed between each of the suction pods/electrodes to perform the ablation, sensing, stimulating and/or mapping. There can be two or more suction pods/electrodes per catheter.
• As shown inFIG. 50, thecatheter63 can includesuction holes5 or pods without the use of multi-tipped configuration described above. Thecatheter63 can incorporatemultiple suction holes5 andelectrodes6 can be placed adjacent to or near the suction holes5 to anchor theelectrodes6 to thetissue83. Movement of thecatheter63 andsuction holes5 along thetissue83 can occur without the use of cables or tension wires for movement. A long continuous energy transmission line along thetissue83 can be created.
• FIGS. 51A-51C show a closer view of thesuction catheter63 creating a long continuous energy transmission line along thetissue83 and the manipulation of the distal tip of thesuction catheter63. Thecatheter63 can be moved over thetissue83 without losing initial position. Thecatheter63 manipulation sequence can vary. In an embodiment, both suction holes5a,5bcan be turned on such that thecatheter63 is anchored onto the tissue83 (FIG. 51A). The suction in the distal hole5acan be turned off and apull wire20 withdrawn proximally to bend thecatheter63 and cause a backward motion (FIG. 51B). Suction can then be turned on in the distal hole5aand turned off in the proximal hole5bto allow thecatheter63 to straighten out (FIG. 51C). The suction can then be turned on in the proximal hole5band energy transmission initiated. This process can be repeated to create an energy transmission line in a first direction (e.g. proximally). Suction can also be activated in the opposite manner such that the catheter is moved forward (e.g. distally). Thecatheter63 can include alaser cut pattern3, for example between each suction hole5a,5bthat increases flexibility and allows for lateral movement of thecatheter63.
• In an alternate design, suction can be turned on to maintain the position but not for anchoring thecatheter63 for movement. In this embodiment, thepush element97 can be used as an alternative to suction forces to oppose the pull force provided by thepull wire20 to bring the distal tip closer to the proximal tip as shown inFIG. 51B. Thepush element97 can also be used to straighten thecatheter63 or to orient it using the flexiblelaser cut pattern3.
• FIGS. 52A-52D illustrate another example of an electrode system including a concentricinner suction catheter4 and anouter electrode catheter71. The inner catheter incorporatingsuction lumen4 can be movable and steerable and can extend beyond the distal tip of theelectrode catheter71. Once the suction tip is firmly anchored onto thetissue83, theelectrode catheter71 can be manipulated to be in contact against thetissue83.Electrodes6 can be mounted on theelectrode catheter71 and can also be mounted at the tip of thesuction catheter4. After an energy transmission line is created theelectrode catheter71 can pivot or swivel around thesuction catheter tip4 and transmit energy to the opposite side without losing its initial position. An irrigation mechanism can be included and used in conjunction with the electrode system to keep the tissue cool during the procedure as described above.
• FIGS. 53A-53E illustrate another embodiment of a suction catheter that includes an expandable portion. Theelectrode catheter27 can include a single aspiration lumen and a movableinner shaft29. Theelectrode catheter27 has an internal lumen with multiple openings which the movableinner shaft29 can translate over and cover. In this manner, theinner shaft29 can selectively control the amount of suction by covering the specific sections of thecatheter27. In this embodiment, no separate suction lumen need be connected to each of the aspiration ends all the way back to the handle. Thecatheter27 can be contained within anouter sheath31 for ease in delivery (seeFIG. 53D). The main body of the electrode catheter27 (between theouter sheath31 and the retractable shaft29) can be made of a flexible or super-elastic material such as Nitinol or other material. Also, shown in this embodiment is a mechanism that allows for the passage of a cooling fluid onto the surface of the catheter throughholes7 to cool theelectrodes6 and the surroundingtissue83.Saline30 can be used for irrigation through theholes7 also as described in more detail above.
• FIGS. 54A-54D show another embodiment of a suction electrode catheter that includes an expandable portion. In this embodiment, the catheter electrode system includesinflatable elements34 havingelectrodes6 disposed thereon, such as on the surface of theinflatable elements34. Theinflatable elements34 can be an inflatable balloon with a corresponding inflation lumen(s)36. Asuction lumen4 and corresponding suction holes5 can formmultiple suction pods67 disposed along the length of the catheter at various intervals that stabilize the catheter and assure good contact with the target tissue to be ablated, for example a moving target tissue such as the myocardium. The catheter between eachsuction pod67 can include alaser cut pattern3 for increased flexibility in positioning of the electrodes, as described herein.FIGS. 54B-54D show the various stages of the catheter from pre-inflation to fully inflated and engaged with the tissue.
• FIGS. 55A-55C show another embodiment of a suction electrode catheter that includes an expandable portion. The catheter electrode system can includeexpandable elements43 havingelectrodes6 disposed thereon. Thelinear electrode catheter71 can use a combination ofexpandable elements43 and aspiration to anchor the device and transmit energy to the target tissue. Theexpandable elements43 can be flexible membranes orballoons having electrodes6 of electro-conductive ink deposited thereon as described above. Theexpandable elements43 can be shaped to create an opening to the tissue when inflated and allow for aspiration and anchoring. Anaspiration lumen4 can connect each of theexpandable elements43 and can be controlled at the handle (not shown). A retractable shaft can be used to control suction of the individual suction pods. In another embodiment, each suction pod can be individually controlled via separate aspiration lumens. The aspiration holes5 create a gap between theaspiration lumen4 and the tissue. This separation allows for the tissue to be drawn into the opening of theexpandable element43 and be in full contact with theelectrodes6 without blocking flow to theaspiration lumen4 itself. The distal end ofelectrode catheter71 can be flexible between each suction pod or may include alaser cut pattern3 and can be manipulated for best apposition to the tissue. Irrigation holes (not shown) can also be included at each suction pod to allow for saline to flow through and prevent clotting of blood in the suction pods. Anelectrode assembly105 that includes one or more suctions elements can be used to treat the internal space of an organ target tissue via electrodes positioned inside or outside the organ. For example, for treatment of atrial fibrillation within the left atrium, the electrode assembly can produce endocardial or epicardial ablation lesion lines.
• FIGS. 56A-56E illustrate various embodiments of a rapidexchange electrode sheath77 that can be positioned over an anchoringcatheter11 that is fixed to the tissue via suction holes5a,5b,5cas described in embodiments above. In this embodiment, theelectrode catheter77 can have one ormore rings64 near the distal end through which the anchoringcatheter11 can extend. Theserings64 as well as the proximal portion of theelectrode catheter77 can be oriented such that they do not obstruct the suction holes5a,5b,5cas shown inFIG. 56A. It should be appreciated that although only three suction holes are depicted in the figure, more or fewer suction holes are considered herein.FIG. 56B shows theelectrodes6 coupled to an anterior portion of one or more of therings64 of thecatheter77 to minimize interference with the suction holes5a,5b, and5c. Anexpandable element66 can be included that has aninside reflecting surface79 to allow for vision through a fiberscope78 with an angle of view82 towards the tissue. The reflectingsurface79 can have holes (not shown) that allow for a mechanism such as a water jet to contact the tissue and provide a clear field of view for the fiberscope78. Although a reflectingsurface79 and water jet are depicted, it should be appreciated that vision can be accomplished with the use of only the fiberscope78.FIG. 56C shows anelectrode catheter77 having a distalcurved tip86 that can press in a downward direction on the anchoringcatheter11. This mechanism helps to keep the suction hole(s)5a,5b,5cagainst the tissue and to provide for a better anchoring.
• FIG. 56D shows a guiding wire85 extending through the anchoringcatheter11 that can be used to orient the anchoringcatheter11 to an optimal or better place for the suction holes5a,5b, and5cto press against the tissue. As mentioned in previous embodiments, the anchoringcatheter11 can be flexible with little torque resistance to enhance its ability to orient the suction holes5a,5b, and5cagainst the surface of the tissue at a variety of angles. The anchoringcatheter11 can also include a retractable hollow shaft84 to provide more rigidity and torque control for placing the suction holes5a,5b,5cagainst the tissue. In an example, a user can orient the wire85 to obtain contact and anchoring of the most distal suction hole5cagainst the tissue. The user can pull back and rotate the shaft84 in combination with manipulating the wire85 to orient the second most distal suction hole5bto contact and engage with the tissue. The next most proximal hole5acan be similarly oriented and the shaft retracted to allow for all the suction holes5a,5b,5cto be actively anchored against the tissue. Once the anchoringcatheter11 is properly oriented and stable, theelectrode catheter77 can be advanced and retracted over the suction holes5 without loosing adhesion against the tissue. This provides for a quicker and more efficient energy transmission, for example for the purpose of ablation and mapping.FIG. 56E shows theelectrode catheter77 movement relative to the anchoringcatheter11 against thetissue83.
Methods of Manufacture and Materials
• Various techniques can be employed in the manufacture of the devices described herein. In an embodiment, theflex circuit89 can be constructed to optimize for an overall low profile of theelectrode assembly105. Theflex circuit89 can havetemperature sensors90 that can be powered through one of the conductive traces16 of theflex circuit89. This eliminates the need for an additional assembly junction on themembrane64. Thetemperature sensors90 can share aconductive trace16 with amapping electrode51. Sharing the conductive traces16 allows fornarrower flex circuits89 and an overall lower profile of theelectrode assembly105. Asingle flex circuit89 can split into at least twobranches87 to reduce the number of parts and ease of assembly. There can be only oneflex circuit89 that splits into all thebranches87 of theflex circuit89 needed to power theelectrodes6. The distal end of theflex circuit branches87 can containsacrificial tabs102 that allow for proper positioning of the branches of theflex circuit89 during assembly.
• The flex circuit main leads17 of theflex circuits89 can be routed from the proximal end (near a handle or actuator) of acatheter shaft57 through the catheter lumen to the distal end. The flex circuit main leads17 can divide into two ormore branches87 and can be folded over themembrane34 from either a proximal region or a distal region of themembrane34. Themembrane34 can be mounted on a temporary mandrel support with inflation ports to maintain a constant expanded state during assembly. The flex circuitsacrificial tabs102 can be mated to an assembly fixture for consistent tensioning of all branches of the flex circuit. The fixture can be designed to hold themembrane34 and theflex circuit89 in a pre-determined position relative to the other. For a streamlined bond of theflex circuit89 to themembrane34, theflex circuit branches87 can be pressed firmly against themembrane34 surface while an agent, such as adhesive, is applied and cured. This can minimize the profile due to, for example, an excessive amount of agent applied. Adhesive can be applied to the underneath surface or bottom substrate layer of theflex circuit89, which will be in contact with themembrane34. This can be accomplished through the use of a robotic system, which can apply precise amounts of adhesive at appropriate locations on theflex circuit89.
• As shown inFIG. 59, the assembly fixture can include a centering andinflation pin106 and thefixture base107. Theflex circuit89 can be inserted through acentral slot108 in thefixture base107 and thebranches87 directed to their respectiveradial pattern slots109. Themembrane34, a toroid-shaped balloon in this example, can be mounted on the centering andinflation pin106 and the pin is inserted through thecenter slot108 of thefixture base107 and secured in place. A regulated, low pressure air supply can be used to inflate themembrane34 to the desired level once on thefixture107. Thesacrificial tabs102 of theflex circuit89 can be mated to the radially-spacedslots109 of the perimeter of thefixture base107, maintaining a consistent position of theflex circuit89 relative to theexpandable membrane34. Once theflex circuit89 and themembrane34 are properly located and secured, the agent can be applied and cured.
• InFIGS. 61A-61C,62A and62B are illustrated various means by which catheter shafts may be interfaced to theexpandable membranes34 associated with theelectrode assembly105.FIG. 61A and detailed viewsFIGS. 61B and 61C illustrate how the outer diameter (OD) of aninner shaft134 and anouter shaft57 may be interfaced to the various surfaces of anexpandable member34. InFIG. 61B is illustrated an expanded view of an interface in which theouter surface135 of theexpandable membrane34 is interfaced to the OD of theinner shaft134 and the inner surface of theexpandable membrane34 is interfaced with the OD ofouter shaft57. InFIG. 61C the interface to the outer shaft remains the same as that illustrated inFIG. 61B, however the inner surface ofexpandable membrane34 is interfaced with the OD ofinner shaft134. Although not shown, a single shaft may also be used to interface with the distal and proximal interfaces of theexpandable membrane34. In this embodiment, a spacer can be used at the distal end. Alternatively, both interfaces on the expandable structure can be fabricated at the same inner diameter (ID).
• FIGS. 62A and 62B illustrate the interface ofFIG. 61B where the expandable member portion of the interface incorporates a thickenedsection35.FIGS. 63A and 63B illustrate the interface ofFIG. 61C where the where the expandable member portion of the interface incorporates a thickenedsection35 and additional structure associated with theelectrode assembly105 are also incorporated. The interface ofFIGS. 63A-63C has particular advantage when presenting electrodes on the distal surface of theelectrode assembly105 as all portions of the shaft to which theexpandable member34 is interfaced reside proximal to the distal end of the shafts on inflation or a portion of theexpandable member34 is substantially distal to the distal end of the assembly or the distal end of the shaft.
• Theelectrodes6 can be sprayed onto theflex circuit89 andmembrane34 while still mounted on the temporary support mandrel. Theelectrodes6 can cover eachconductive pad59 for electrical connection to theflex circuit trace16 and a relatively large portion of the surroundingmembrane34 surface and over the insulated portions of theflex circuit89 itself. Theelectrodes6 can be formed by using a mask over themembrane34 during the deposition process, which can spray over the membrane and the mask alike. Once the ink is cured, the mask can be removed. An alternate technique is to use automated robotic systems which may be programmed to precisely and accurately spray only the desired electrode surfaces without the presence of a mask.
• Theelectrodes6 can be formed before or after the flex circuit is bonded to the base membrane structure.FIG. 2A shows anelectrode6 deposited onto themembrane34 first. Thetrace16 of theflex circuit89 can be laid over themembrane34 with theconductive pad59 positioned directly over theelectrode6. An electrically conductiveadhesive layer95 can be laid over portions of theelectrode6 to adhere to the exposedconductive layer96. Non-conductive adhesive95 can be used to bond to the rest of themembrane34 andtrace16.FIG. 2B shows that thetrace16 can be first bonded to themembrane34 using an adhesive which does not need to be conductive. Theconductive pad59 can face outward from themembrane34 surface such that it is not in direct contact with themembrane34. Theelectrode6 can then be laid over theconductive pad59, the adjacentinsulated flex circuit89 portion, and themembrane34.
• FIG. 2C shows thetrace16 of theflex circuit89 traveling from inside themembrane34 through the membrane surface. Theelectrode6 can alternatively be placed first, in which case the exposedconductive pad59 of thetrace16 can face inwards to be in contact with theelectrode6.FIG. 2D shows theflex circuit89 manufactured at the same time as themembrane34. As shown, a layer ofmembrane34 material can be the inner-most layer, followed by placement of theflex circuit89 and traces16 with the exposedconductive pad59 facing out. Theconductive pad59 of thetrace16 can be masked to deposit the remaining layers of membrane material to encapsulate theflex circuit89. Lastly, theelectrode6 can be laid over the exposedconductive pad59 of thetrace16 and themembrane34. Theelectrode6 in this embodiment can also be a polymer impregnated with conductive material.FIG. 2E shows an embodiment where theelectrode6 is manufactured at the same time as themembrane34. Theelectrode6 can be embedded with themembrane34 layer and the electrode material may be impregnated with the membrane material to enhance adherence. Thetrace16 can then be placed over theelectrode6 with the exposedconductive pad59 in contact with theelectrode6.
Methods of Use
• As described previously, the devices and method described herein are not limited to use for atrial fibrillation. It should be appreciated that the following is for example only and that other indications are considered herein.
• The devices described herein can be used for the ablation of the myocardium, for example for the treatment of atrial fibrillation. The pulmonary veins, which are known to cause irregular signals, can be electrically isolated from the rest of the atrium. Aberrant tissue on other areas of the atrium that can cause irregular electrical signals can be found and ablated. The electrode assemblies described herein can conform to the different anatomical sites within the atrium to electrically eliminate these abnormal signals. In an embodiment, the electrode assembly for use in treating atrial fibrillation includes a balloon shaped membrane in the shape of a sphere or a toroid allowing for large diameter to be positioned against the antrum of the pulmonary vein for circumferential lesions. Another site where such electrode assemblies have application is in the treatment of mitral prolapse. In this treatment the electrode structure may delivered to the mitral valve, inflated, such that the electrode structures interface with the annulus of the mitral valve. When lesions are induced in the annulus of the mitral valve, the collagenous tissues comprising the annulus will shrink. Such treatments are effected by other means with the outcome of decreasing mitral valve regurgitation. Such a treatment can be useful in any of the valves of the heart. Alternatively, an electrode assembly incorporating a cylindrical balloon shaped membrane element may be used to treat atrial fibrillation within the pulmonary vein, where a helical lesion pattern can be used to advantage as a means of limiting stenosis resultant from the ablative injury. Yet another site where such a configuration has particular advantage is in the treatment of hyper tension by ablating sympathetic nerves peripheral to the renal arteries. The ability to create a helical lesion within the renal artery without requiring repositioning of the electrode structure, either by activation of a set of helically arrayed electrodes or addressing a subset of a rectilinear array to create a helical lesion as described herein has advantage over the art presently in use. With reference to the luminal treatments just described, patterns other the helical lesion can provide the same outcome. Such patterns are those in which the projection of lesions on a plane normal to the long axis of the treatment lumen create a complete circle of overlapping regions.
• In an embodiment, theelectrode assembly105 can be sheathed using asheathing fixture103 and introduced into a sheath that is placed at the appropriate entry point, the femoral vein for example (seeFIGS. 57A-57C). Thesheathing fixture103 can be a block with a predefined internal diameter for theelectrode assembly105. Thefixture103 can be manufactured as two halves that are slidable and interlockable to each other as shown inFIG. 57A. Asheathing tube104 can be used in conjunction with thesheathing fixture103 in that thetube104 can slide into thesheathing fixture103 until it reaches a hard stop as shown inFIGS. 57B and 57C. The inner diameter of thetube104 can match that of thefixture103. To sheath theablation assembly105, the catheter can be placed within thesheathing fixture103 such that theassembly105 is outside of thefixture103 at one end as shown inFIG. 58A. Theshaft57 can also be placed with the two halves of thesheathing fixture103 still separated. Theassembly105 can be pulled into the inner portion of thesheathing fixture103. Thetube104 can be inserted into thefixture103 until it reaches a hard stop. Theshaft57 and theelectrode assembly105 can be pushed into thetube104 and seated within thetube104. Once theassembly105 andshaft57 are securely sheathed into thetube104, thefixture103 can be removed from theassembly105 by separating the two halves of thesheathing fixture103. Thesheathing tube104 can be to introduce theassembly105 into a sheath that is placed to reach the desired target tissue. Theassembly105 is then pushed out of thesheathing tube104 and travels within the introducer to reach the target site. Thesheathing tube104 remains proximal to the assembly and does not travel within theintroducer sheath117.
• An alternate means of sheathing prior to introduction to the introducer is illustrated inFIGS. 58F-58H. The three primary stages of this process are represented inFIGS. 58F-58H and are described as follows. In this embodiment analternate sheathing tube128 is mounted on theouter shaft57 at the time of manufacture as shown inFIG. 58F. Thesheathing tube128 andassembly105 are moved relative to one another such thatassembly105 is collapsed byalternate sheathing tube128 as indicated inFIG. 58G. As the relative motions are continuedelectrode assembly105 is captured and contained within the alternate sheathing tube as shown inFIG. 58H. Thealternate sheathing tube128 andelectrode assembly105 are then introduced through anintroducer valve126 into theintroducer sheath127.Sheathing tube128 may be a short section which interfaces with the proximal section ofouter shaft57, or may be close to the entire length of theouter shaft57 such that it can be operated from the handle and can be used while theelectrode assembly105 is resident in within the luminal system under treatment.
• In yet another embodiment a sheathing tube may or may not be required. This embodiment is represented inFIGS. 58I-58K. In this embodiment theinner shaft58 and theouter shaft57 are moved relative to one another such that theelectrode assembly105 is shifted from its expanded configuration to a delivery configuration as indicated in the transition pictured from58I-58J. As illustrated inFIG. 58K,electrode assembly105 is shifted intointroducer sheath128 through andintroducer valve126 and the device is ready for transport to the treatment site. Alternately, the device in the configuration ofFIG. 58J may be delivered with a sheathing tube such as those described herein.
• Thealternate delivery sheath128 is illustrated inFIG. 65. The alternate sheathing tube can have multiple tubing layers and is configured to be captured on the outer shaft and present a soft and compliant member at the interface to theelectrode assembly105. It is typically mounted on the outer shaft at the time of manufacture. The device is described as follows. Asoft jacket129 fabricated from a compliant material such as PEBAX encapsulates at least the distal end of astiff jacket130. Thesoft jacket129 also extends beyond the distal end of thestiff jacket130 such that as thealternate delivery sheath128 interfaces with the electrode assembly105 a compliant member is presented assuring no damage to the electrode assembly occurs as it is being compressed into its sheathed configuration. Thestiff jacket130 can be manufactured of stiff materials such as polyimide. This proximal end of this assembly is surrounded by base tube122 which can be manufactured of materials having strength such as polyimide. At the proximal end mounted within thebase tube132 is thestop tube131 which is configured to collide with a feature on the outer shaft57 (not shown). Thestop tube131 can be manufactured of materials such as polyimide. Given the characteristics of the materials presented others can be appropriately chosen as replacements by those with knowledge in the art.
• Theassembly105 can be delivered to the left atrium and the membrane expanded and placed at the antrum of one of the pulmonary veins. The overall shape of the membrane can be visualized using the electrodes themselves as the conductive metallic material of the electrodes can provide visualization under fluoroscopy. The radiopaque markers can be used to determine exact location of each electrode based on the marker orientation. The mapping electrodes can be used to measure initial electrical signals and can later confirm electrical conduction block post ablation. The user can select which electrodes to turn on, which ones to leave off, and which ones to set to a higher or lower power setting based on their contact with the tissue. The various methods of contact detection as described above or a fiber optic can be used to confirm contact of the electrodes with the tissue. The device is then set to the appropriate power and temperature settings, irrigation turned on to the desired level, and energy transmission initiated. The mapping electrodes can be used now to determine successful conduction block. Once conduction block is achieved, the catheter and moved over to the next target location, another pulmonary vein or atrial wall, for ablation.
• FIG. 64 illustrates acomplete system1000 for using theelectrode assembly105. The system incorporates avisualization system1004, a source ofablative power1002, anirrigation fluid source1003 interfaced to a pump possibly incorporating an irrigation fluid cooling means1005, aninterface cable1001, acatheter handle1006 incorporating additional controls, a catheter incorporating ashaft57 connected to the distal end of theelectrode assembly105 and associated inner assemblies, theelectrode structure105, and aguide wire1007.
• It should be appreciated that variations of the disclosed devices, assemblies, and methods can exist. It should also be appreciated that a variety of elements described herein can be used individually or in a variety of combinations. Features described herein in the context with or respect to one exemplary device or assembly can be implemented separately or in any suitable sub-combination with other exemplary devices or systems.
• It is to be understood that this subject matter described herein is not limited to particular embodiments described, as such may of course vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless defined otherwise, all technical terms used herein have the same meaning as commonly understood by one skilled in the art to which this subject matter belongs.
• While this specification contains many specifics, these should not be construed as limitations on the scope of what is claimed or of what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Only a few examples and implementations are disclosed. Variations, modifications and enhancements to the described examples and implementations and other implementations may be made based on what is disclosed.

Claims (27)

What is claimed is:

1. A catheter and electrode assembly comprising:

an elongate catheter body comprising a distal portion;

an expandable electrode structure coupled to the distal portion,

wherein the expandable electrode structure comprises

an expandable membrane with an expanded configuration, and

a branched flexible circuit having a substrate layer and planar conducting layer electrically coupled to a plurality of radio frequency ablation electrodes and at least one sensing electrode,

wherein in the expanded configuration at least four of the electrodes are disposed in an array on a distal surface of the membrane.

2. The assembly ofclaim 1, wherein the at least four electrodes are adapted to be substantially coplanar with a distal tip of the catheter body when the membrane is in the expanded configuration.

3. The assembly ofclaim 1, wherein the at least four electrodes are distal to the distal tip of the catheter when the membrane is in the expanded configuration.

4. The assembly ofclaim 1, wherein a first membrane portion comprising at least 15% of the surface area of the membrane is distal to a distal tip of the catheter body, and wherein the at least four electrodes are disposed on the first membrane portion.

5. The assembly ofclaim 1, wherein at least 10% of the volume of the membrane is distal to a distal tip of the catheter when the membrane is in the expanded configuration.

6. The assembly ofclaim 1, wherein first and second opposite sides of a surface of the membrane are coupled to the catheter body.

7. The assembly ofclaim 1, wherein a plurality of perforation holes traverse the membrane.

8. The assembly ofclaim 1, further comprising an annular introducer wherein the introducer surrounds the expandable membrane and confines the diameter thereof to less than about 0.2 inches.

9. The assembly ofclaim 8, wherein the introducer is adapted to engage a collapsed exterior of the expandable membrane and confine a portion of the membrane substantially distal to the distal end of the catheter body.

10. The assembly ofclaim 1 wherein the expanded configuration is an inflated configuration.

11. A unitary flexible circuit comprising:

a proximal end, a distal end, and an intermediate portion, wherein

the proximal end is coupled to an electrical source,

the intermediate portion is comprised of a plurality of flexible branches separated from one another along their lengths, wherein at least one branch has an insulating layer along a portion thereof and at least one branch is electrically connected to an electrode adapted to deliver radio frequency energy, wherein the flexible branches conform to a portion of a medical device adapted to be minimally-invasively delivered to a location within a subject,

and wherein the plurality of branches are coupled to one another distal to the intermediate portion.

12. The unitary flexible circuit ofclaim 11, wherein the length of at least one branch in the intermediate portion is between about 1 cm and about 5 cm.

13. The flexible circuit ofclaim 11 wherein the flexible branches conform to a radially outer surface of the portion of the medical device.

14. The unitary flexible circuit ofclaim 11, wherein the branches of the intermediate portion conform to the portion of the medical device such that they are oriented in a configuration surrounding a longitudinal axis of the medical device.

15. The unitary flexible circuit ofclaim 14, wherein the branches extend substantially 360 degrees around the longitudinal axis and at least two of the plurality of branches are separated by more than 30 degrees from an adjacent branch.

16. The unitary flexible circuit ofclaim 11, wherein any two branches are separated by more than 10 degrees.

17. The unitary flexible circuit ofclaim 11, wherein any two branches are separated by more than 90 degrees.

18. The unitary flexible circuit ofclaim 11, wherein the plurality of branches of the intermediate portion are fixed on the medical device such that the medical device maintains the separation between the branches.

19. The unitary flexible circuit ofclaim 18, wherein the portion of the medical device is an expandable membrane.

20. The unitary flexible circuit ofclaim 19, wherein the orientation of the branches of the intermediate portion depends on the inflation of the expandable membrane.

21. The unitary flexible circuit ofclaim 20, wherein a portion of the expandable membrane and a portion of a plurality of the branches are located distally to the distal end when the expandable membrane is in an expanded configuration.

22. The unitary flexible circuit ofclaim 11, wherein at least two of the branches are comprised of a plurality of electrodes adapted to deliver radio frequency (RF) energy.

23. The unitary flexible circuit ofclaim 22, wherein the distal end is comprised of a sensing electrode spaced apart from the plurality of electrodes.

24. The unitary flexible circuit ofclaim 11, wherein the proximal end is coupled to a catheter.

25. The unitary flexible circuit ofclaim 24, wherein the catheter is sealed along a length thereof extending from the proximal end to the intermediate portion.

26. The unitary flexible circuit ofclaim 11, wherein at least three branches terminate in a connector at the proximal end.

27. The unitary flexible circuit ofclaim 11, wherein portions of the medical device are adapted to be folded by selective orientation of the plurality of branches.

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